Effects of Dextrose Versus Saline Infusion on Intrathecal Morphine-Induced Postoperative Nausea and Vomiting During Gynecological Abdominal Surgeries: Randomized Controlled Double-blind Study

December 5, 2024 updated by: Fareed Fathy Wadea, Assiut University

Neuraxial anesthesia, which includes epidural anesthesia and intrathecal anesthesia, is a frequent anesthetic approach for cesarean delivery and other lower abdominal and lower limb anesthetic procedures.

Neuraxial morphine (intrathecal or epidural administration) provides high-quality analgesia after gynecological abdominal surgeries.

the aim of the study is to compare the effects of intraoperative infusion of dextrose 5 % and 10 % versus normal saline 0.9 % on the incidence of intrathecal morphine-induced postoperative nausea and vomiting (PONV) in women undergoing gynecological abdominal surgeries. (Neuraxial anesthesia).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The use of intrathecal opioids for postoperative analgesia was introduced in 1979. There have been many pharmacodynamic and pharmacokinetic studies of intrathecal opioids and the mechanism of action-producing analgesic effects by direct action at the spinal cord level. The addition of intrathecal opioids to bupivacaine for spinal anesthesia may provide clinical advantages such as improved intraoperative conditions and postoperative analgesia. Adverse effects range from nausea and vomiting that, although not life-threatening, are major nuisances to the patient, to more severe effects, including sedation and life-threatening respiratory depression.

Nausea is an unpleasant sensation causing discomfort in the stomach area which gives the feeling of the impending need to vomit or retch. It is often a transient sensation which is frequently followed by active retching or tachycardia and increased salivation. Vomiting is the involuntary, forceful expulsion of the contents of the stomach through the mouth and/or nose. The incidence of these side effects varies from 30-80 % after elective surgery depending on the type of anesthesia and surgery as well as predisposing patient risk factors.

Postoperative nausea and vomiting (PONV) describes nausea and/or vomiting or retching occurring in the post-anesthesia care unit (PACU) or during the first 24-48 hours after surgery. Post-discharge nausea and vomiting (PDNV) refers to symptoms that occur after discharge from the hospital or surgical care facility. Not only is PONV a distressing complication from the patient's perspective but also it can result in dehydration, electrolyte imbalance, acid base imbalance, pulmonary aspiration, pneumothorax, hypoxia, esophageal rupture, increased intracranial pressure, suture rupture, wound dehiscence, bleeding, delay in the ability to resume oral intake, prolonged PACU and/or hospital stay, fatigue, anxiety, unanticipated hospital admission or readmission, and increased medical costs. The distressing symptoms of PONV/PDNV also contribute to patient dissatisfaction with their surgical experience. PONV prophylaxis is economically beneficial for the hospital when a rational multimodal program is implemented based on patient and procedural risk factors.

Enhanced recovery programs in surgical patients and the promotion of day case surgery both require and include adequate prophylaxis of PONV. There are dozens of different anti-emetic drugs, mostly within the drug classes of 5- hydroxytryptamine-3 (5HT3), dopamine-2 (D2) and neurokinin-1 (NK1) receptor antagonists, corticosteroids, antihistamines and anticholinergics. Varying adverse effects have been attributed to the six different substance classes, such as headache and constipation (5-HT3 receptor antagonists); extrapyramidal symptoms, sedation, arrhythmia and QT prolongation (D2 receptor antagonists); hyperglycemia, immunosuppression and poor wound healing (corticosteroids); drowsiness, dry mouth and urinary difficulties (antihistamines); and dry mouth and visual disturbances (anticholinergics).

In addition to pharmacological therapy, recent studies are assessing the impact of fluid therapy in the prevention of PONV, finding that the use of crystalloids in ASA I and II patients receiving general anesthesia reduces the risk of postoperative nausea. and a preventive effect of vomiting during the first 24 hrs post-surgery[15]. Another fluid therapy strategy for PONV is the administration of colloids, which has had a superior effect in preventing PONV than the administration of crystalloids in patients undergoing lower abdominal surgery who received general anesthesia for 3 hours or more[16]; however, these results are not the same in patients who received general anesthesia for less than 3 hours. On the other hand, the administration of bolus glucose solution is still very controversial, since some results show that it does not reduce PONV [17], while Chisaki et al. (2020) reported its usefulness in reducing postoperative nausea, but not vomiting.

These last fluid therapy recommendations should be handled with caution, since the risk of serious adverse events resulting from the supplementary administration of intravenous crystalloids and colloids is unknown, and it is not clear whether patients are at risk of being readmitted to the hospital postoperatively due to these interventional measures.

Study Type

Interventional

Enrollment (Estimated)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 20 - 60 years. Females of American Society of Anesthesiologists (ASA) class I or II physical status.

Elective gynecological abdominal surgeries under intrathecal anesthesia.

Exclusion Criteria:

  • Patient refusal. Patients with a history of PONV, smoking, motion sickness or diabetes mellitus. Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).

Morbid obesity (BMI >35 kg/m²). Patients with known hypersensitivity to morphine or amide local anesthetics. Patients with any contraindication for intrathecal anesthesia, e.g. coagulopathy.

Emergency operations. Psychiatric disorders or patients who are unable to understand the verbal rating scale.

Failed or unsatisfactory intrathecal block. Patients currently receiving opioids, steroids, antiemetic drugs or chemotherapy, pregnant females, and those with abnormal blood glucose on the morning of surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: group I
patients will receive infused IV 0.9 % saline
Drug: 0.9% saline
patients will receive infused IV 0.9 % saline
Experimental: Study group II
patients will receive 5 % dextrose infusion
Drug: dextrose 5%
patients will receive 5 % dextrose infusion
Experimental: Study group III
patients will receive 10 % dextrose infusion (25gm/ 250 mL)
Drug: Dextrose 10%
patients will receive 10 % dextrose infusion (25gm/ 250 mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative nausea and vomiting( PONV)
Time Frame: 24 hours
Incidence of PONV during the first postoperative 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dextrose vs Saline Gyn surg

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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