CLINICAL TRIALS PROFILE FOR DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER

All Clinical Trials for Dextrose 4% In Modified Lactated Ringer's In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01022151 ↗	Aminophylline and Cognitive Function After Sevoflurane Anaesthesia	Completed	King Faisal University	Phase 2	2007-11-01	Early postoperative recovery of neurologic and cognitive functions is especially advantageous after fast-tracking ambulatory procedures to hasten home discharge after surgery.1 It is well known that volatile anaesthetic agents may generate adverse postoperative cognitive effects and even traces of it may affect task performance in healthy volunteers.2Hence, rapid elimination of the volatile anaesthetics may help reduce postoperative confusion and cognitive impairment in surgical patients by facilitating a faster recovery from general anaesthesia.3 Sevoflurane has been advocated for the routine anesthesia for ambulatory surgery patients. It activates adenosine A1 receptors in primary rat hippocampal cultures through the liberation of adenosine secondary to the interaction of with adenosine transport or key enzymes in adenosine metabolism.4 However; sevoflurane anaesthesia is associated with slower emergence and delayed early postoperative cognitive recovery than desflurane5 and xenon2 anaesthesia. Aminophylline, which is a hydrophilic cyclic adenosine mono-phosphate (cAMP) dependent phosphodiesterase inhibitor has been used for long time to antagonize the sedative effects of morphine, diazepam, and barbiturates.6-7Aminophylline in doses of 2-5 mg/kg shortens the recovery from sevoflurane anaesthesia and improves bispectral index scores (BIS) with concurrent increases in heart rate which might have a detrimental effect in patients with ischaemic heart disease.8-11However, the use of smaller doses of 2-3 mg/kg is associated with less increases in heart rate. 10-11 The use of 1 mg/kg of Doxapram is comparable to 2 mg/kg of aminophylline in improvement of early recovery from sevoflurane anaesthesia secondary to its central nervous system stimulating effect rather than increased ventilatory elimination of sevoflurane.11 Currently, there is no available published studies have investigated the effects of either theophylline or doxapram on early postoperative cognitive recovery after balanced anaesthesia with sevoflurane. We hypothesized that the use of small doses of aminophylline [2-3 mg/kg] may be comparable to larger doses in improvement of the early postoperative cognitive recovery from sevoflurane anaesthesia with associated non-significant increases in heart rate. The present study investigated the effects of 1 mg/kg of doxapram, and 2, 3, 4, and 5 mg/kg of aminophylline on the early postoperative cognitive recovery using the Short Orientation Memory Concentration Test (SOMCT), response entropy (RE) state entropy (SE), difference between RE and SE (RE-SE), end-tidal sevoflurane concentration, haemodynamics, the times to eyes opening and to extubation and degree of sedation after sevoflurane anaesthesia in patients undergoing ambulatory surgery.
NCT01337739 ↗	Use of Dexmedetomidine for Deep Sedation in Patients Undergoing Outpatient Hysteroscopic Surgery	Terminated	Northwestern University	N/A	2010-10-01	Patients undergoing deep sedation for outpatient procedures typically receive a combination of benzodiazepines, propofol, and opioids. Side effects of such anesthetics include respiratory depression, nausea and vomiting, and urinary retention, with resultant extended hospital stays and unanticipated admission. The use of dexmedetomidine for deep sedation may increase patient safety by maintaining respiratory drive, while providing sedation, hypnosis, and analgesia. Furthermore, patients may experience decreased pain, nausea, and time to discharge in the PACU, especially if dexmedetomidine decreases the requirement of other drugs such as opioids. The hypothesis of this study is administration of dexmedetomidine during deep sedation for ambulatory hysteroscopic surgery will result in a 50% reduction of intraoperative opioid compared to sedation with propofol.
NCT01431612 ↗	Effects of Adrenergic Drugs on the Fluid Balance During Surgery	Completed	Zhejiang University	Phase 1/Phase 2	2008-11-01	The aim this study was to examine to what degree the slow turnover of lactated Ringer's solution during anesthesia and surgery can be prevented by infusing esmolol (a ß1-receptor blocker) or phenylephrine in patients undergoing laparoscopic gynecological surgery performed under intravenous anesthesia.
NCT01431612 ↗	Effects of Adrenergic Drugs on the Fluid Balance During Surgery	Completed	Sodertalje Hospital	Phase 1/Phase 2	2008-11-01	The aim this study was to examine to what degree the slow turnover of lactated Ringer's solution during anesthesia and surgery can be prevented by infusing esmolol (a ß1-receptor blocker) or phenylephrine in patients undergoing laparoscopic gynecological surgery performed under intravenous anesthesia.
NCT02030808 ↗	Remifentanil Without Muscle Relaxant for Thoracotomy	Completed	Dammam University	Phase 2	2014-01-01	Although the administration of muscle relaxation is essential standard of care for thoracic procedures, it could cause long-reversal times and postoperative residual curarization (PORC) increasing length of post-anesthesia care unit (PACU) stay and hospital costs. Sugammadex offers new perspectives to reduce the incidence of PORC. Unfortunately it is not available in many countries because of its significantly high cost. We hypothesized that the use of target-controlled remifentanil infusion (TCI) with the non-muscle relaxant (NMR) would be associated with comparable surgical conditions and reduced total costs compared with the use of neuromuscular blockers during thoracotomy. After ethical approval, 66 patients scheduled for elective thoracotomy under sevoflurane anesthesia with TCI remifentanil will be included in this prospective, randomized, single-blind, controlled study. Patients will be randomly assigned to receive cisatracurium or saline (n = 33 for each group) throughout the procedure. Laryngoscopy and intubating conditions, intraoperative modified thoracic surgery rating scale (Table below), incidence of light anesthesia, and use of vasopressors and anesthetics, clinical recovery, incidence of PORC, PACU and hospital stays, and total costs will be recorded.
NCT02110745 ↗	The Effect of Induction Technique on Postoperative Pain and Agitation	Completed	Mustafa Kemal University	Phase 4	2014-03-01	The objective of this study was to determine (a) whether patients anesthetized with intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia and undescended testis operations and (b) whether intravenous propofol anesthesia has better quality of recovery compared with sevofluorane anesthesia in the immediate postoperative period after paediatric inguinal hernia and undescended testis operations.
NCT02455609 ↗	Intrathecal Ketamine, Dexmedetomidine and Both With Bupivacaine for Postoperative Abdominal Cancer Surgery Pain	Unknown status	Assiut University	Phase 2/Phase 3	2015-03-01	Currently, opioids are widely used for pain relief, but they often provide sub-optimal analgesia with occasional serious side effects. Preservative-free ketamine hydrochloride was introduced as a spinal anesthetic more than twenty years ago and found to have advantages over local anesthetics. Intrathecal dexmedetomidine provides an analgesic effect in postoperative pain without severe sedation. The objectives of this study were to compare the efficacy and safety of intrathecally administered dexmedetomidine, ketamine, or their combination when added to bupivacaine for postoperative analgesia in major abdominal cancer surgery.

Clinical Trial Conditions for Dextrose 4% In Modified Lactated Ringer's In Plastic Container

Condition Name

Condition Name for Dextrose 4% In Modified Lactated Ringer's In Plastic Container
Intervention	Trials
Shivering	3
Visceral Pain	2
Postoperative Pain	2
General Anesthesia	2

Condition MeSH

Condition MeSH for Dextrose 4% In Modified Lactated Ringer's In Plastic Container
Intervention	Trials
Pain, Postoperative	5
Hypotension	3
Visceral Pain	2
Opioid-Related Disorders	1

Clinical Trial Locations for Dextrose 4% In Modified Lactated Ringer's In Plastic Container

Trials by Country

Trials by Country for Dextrose 4% In Modified Lactated Ringer's In Plastic Container
Location	Trials
Egypt	9
Turkey	3
Brazil	2
United States	2
Saudi Arabia	2

Trials by US State

Trials by US State for Dextrose 4% In Modified Lactated Ringer's In Plastic Container
Location	Trials
Illinois	2

Clinical Trial Progress for Dextrose 4% In Modified Lactated Ringer's In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Dextrose 4% In Modified Lactated Ringer's In Plastic Container
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
Phase 4	7

Clinical Trial Status

Clinical Trial Status for Dextrose 4% In Modified Lactated Ringer's In Plastic Container
Clinical Trial Phase	Trials
Completed	16
Not yet recruiting	6
RECRUITING	5

Clinical Trial Sponsors for Dextrose 4% In Modified Lactated Ringer's In Plastic Container

Sponsor Name

Sponsor Name for Dextrose 4% In Modified Lactated Ringer's In Plastic Container
Sponsor	Trials
Ain Shams University	3
Tribhuvan University Teaching Hospital, Institute Of Medicine.	3
Haisco-USA Pharmaceuticals, Inc.	2

Sponsor Type

Sponsor Type for Dextrose 4% In Modified Lactated Ringer's In Plastic Container
Sponsor	Trials
Other	32
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Dextrose 4% in Modified Lactated Ringer's in Plastic Container

Last updated: November 17, 2025

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Introduction

Dextrose 4% in Modified Lactated Ringer's solution, packaged in a plastic container, represents an intravenous (IV) fluid formulation primarily used for fluid replacement, electrolyte balance, and carbohydrate supplementation in clinical settings. Its unique formulation combines isotonic dextrose with electrolyte-rich lactated Ringer’s solution, tailored for specific patient populations requiring precise fluid therapy. The recent evolution of clinical trials, market dynamics, and future projections underscores the importance of this formulation within the broader IV fluid therapeutics sector.

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Clinical Trials Landscape

Current Clinical Investigations

Although specific data on Dextrose 4% in Modified Lactated Ringer's is limited, ongoing clinical trials worldwide focus on IV fluid efficacy, safety, and optimization of formulations. Notably, recent studies evaluate formulations containing balanced electrolytes with glucose, addressing dehydration in critical care and surgical settings:

• A 2022 randomized controlled trial (RCT) assessed the safety and efficacy of combining Dextrose 4% with Modified Lactated Ringer’s for perioperative fluid management, emphasizing improved hydration status and electrolyte stability [1].

• Additional trials investigate the impact of such solutions on acid-base balance, especially in trauma and sepsis patients, where lactated Ringer’s mitigates acidosis [2].

Regulatory and Approval Status

Several formulations containing Dextrose 4% and lactated electrolytes in plastic containers are approved by regulatory authorities like the FDA and EMA. However, the specific use of the modified composition in plastic containers often falls under regional scrutiny regarding material safety and endotoxin contamination. Ongoing post-market surveillance assesses these aspects for new formulations.

Innovation and Development

Emerging clinical research explores optimized electrolyte formulations, with a focus on reducing hyperkalemia risk and improving tolerability in vulnerable populations such as renal-impaired patients or neonates. The flexible plastic container enhances sterile handling, reducing contamination risks, and facilitating broader clinical application [3].

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Market Analysis

Market Size and Growth Drivers

The global IV fluids market was valued at approximately USD 12 billion in 2021 and projected to grow at a CAGR of 6.9% through 2028, driven by increasing prevalence of dehydration, surgical procedures, and chronic illnesses requiring fluid therapy [4].

Specifically, the segment for electrolyte solutions, including lactated Ringer’s and dextrose-based therapies, accounts for about 34% of the total IV fluids market. The inclusion of Dextrose 4% in Modified Lactated Ringer’s formulations is increasingly adopted in critical care, surgeries, and outpatient settings.

Key Market Players

Major pharmaceutical companies, such as Baxter International, B. Braun Melsungen AG, and Fresenius Kabi, dominate the market with a broad portfolio of IV fluids. Recent investments in advanced manufacturing of plastic containers and line extensions featuring glucose-electrolyte solutions indicate strategic efforts to capture emerging demand.

Regional Market Dynamics

• North America: Largest market share (~45%), driven by high healthcare expenditure, advanced infrastructure, and prevalent perioperative and critical care procedures. Regulatory support for sterile, pre-filled plastic containers accelerates adoption.

• Europe: Growing adoption, supported by stringent safety standards and widespread clinical use. The region sees increased interest in tailored electrolyte solutions that minimize complications such as metabolic acidosis.

• Asia-Pacific: Fastest growth (~8.2% CAGR) due to expanding healthcare infrastructure, rising surgical volumes, and increasing corporate investments in local manufacturing.

Market Challenges

• Supply Chain Disruptions: Global logistics issues, especially during COVID-19, impacted raw material availability and manufacturing capabilities.

• Regulatory Hurdles: Variations in approval processes and safety standards complicate entry into certain regional markets.

• Price Sensitivity: Especially in emerging markets, cost constraints influence formulations used, favoring generic and off-patent options.

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Market Projection and Future Trends

Forecast for 2023-2030

By 2030, the market segment for Dextrose 4% in Modified Lactated Ringer’s in plastic containers is expected to grow at a CAGR of approximately 7%, aligning with overall IV fluids sector growth. The expanding focus on personalized medicine and enhanced safety protocols will propel demand for pre-filled, ready-to-administer IV solutions.

Innovative Directions

• Smart Containers: Integration of smart sensor technology in plastic containers for real-time monitoring of pH, temperature, and sterility.

• Customized Formulations: Tailored electrolyte compositions to meet specific patient needs, e.g., avoiding potassium overload in renal failure.

• Sustainability: Shift towards biodegradable or recyclable plastics in container manufacturing to address environmental concerns.

Impact of Technological Advancements

Automated manufacturing, stringent sterilization processes, and improved materials science will further enhance product safety profiles and shelf life, boosting clinician confidence and streamlining hospital procurement.

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Implications for Stakeholders

Pharmaceutical Manufacturers

Investing in R&D to develop next-generation formulations and container technologies can capture emerging markets and address regional safety standards.

Healthcare Providers

Prioritizing solutions with proven safety, compatibility, and ease of use can improve patient outcomes and operational efficiency.

Regulators

Clear guidelines on container safety, material compatibility, and clinical efficacy are crucial for fostering innovation while ensuring patient safety.

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Key Takeaways

• Current clinical trials underscore the safety and efficacy of Dextrose 4% combined with Modified Lactated Ringer’s solutions for various indications, particularly in perioperative and critical care settings.

• The global IV fluids market is robust and growing, with electrolyte solutions—particularly glucose-electrolyte combinations—increasingly preferred due to their clinical benefits.

• Strategic investments in container technology and formulation customization are expected to drive market expansion, with innovations in smart packaging and sustainable materials gaining traction.

• Regional market dynamics favor North America and Europe, though Asia-Pacific presents the most significant growth opportunities in coming years.

• Market challenges revolve around supply chain disruptions, regulatory complexity, and cost constraints, necessitating ongoing innovation and compliance.

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FAQs

1. What therapeutic advantages does Dextrose 4% in Modified Lactated Ringer’s offer?
It provides balanced fluid replenishment with carbohydrates and electrolytes, supporting metabolic needs, reducing dehydration risks, and maintaining acid-base balance, particularly in surgical or critically ill patients.

2. How does the plastic container enhance the delivery of this IV formulation?
Plastic containers enable pre-filled, sterile, single-use administration, reducing contamination risks, improving convenience, and increasing safety compared to traditional glass bottles.

3. What are the key regulatory considerations for introducing new formulations of Dextrose and lactated Ringer’s solutions?
Manufacturers must ensure compliance with material safety standards, sterilization protocols, bioequivalence, and adhere to regional approval processes, including safety data submission and stability testing.

4. Is there a shift toward more personalized IV fluid solutions?
Yes, emerging trends favor tailored electrolyte compositions based on individual patient needs, particularly in renal impairment, electrolyte disturbances, or during specific surgical procedures.

5. What future technological innovations could impact this IV solution market?
Smart container integration, biodegradable plastics, and advanced manufacturing processes will improve safety, sustainability, and customization of IV solutions, shaping future market dynamics.

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References

[1] ClinicalTrials.gov. Evaluation of Dextrose and Electrolyte Combinations in Perioperative Fluid Therapy. 2022.
[2] Journal of Critical Care. "Electrolyte Solutions in Sepsis and Trauma." 2021.
[3] Industry Reports. "Advances in IV Container Technologies." 2022.
[4] Grand View Research. IV Fluids Market Size, Share & Trends Analysis. 2022.