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

NCT06726980 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Dextrose vs Saline Gyn surg
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Gynecological Abdominal Surgeries

Keywords

Nausea; Vomiting; Dextrose

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting( PONV)

  Incidence of PONV during the first postoperative 24 hours

  24 hours

Study Arms (3)

group I

PLACEBO COMPARATOR

patients will receive infused IV 0.9 % saline

Drug: 0.9% saline

Study group II

EXPERIMENTAL

patients will receive 5 % dextrose infusion

Drug: dextrose 5%

Study group III

EXPERIMENTAL

patients will receive 10 % dextrose infusion (25gm/ 250 mL)

Drug: Dextrose 10%

Interventions

dextrose 5% DRUG

patients will receive 5 % dextrose infusion

Study group II

Dextrose 10% DRUG

patients will receive 10 % dextrose infusion (25gm/ 250 mL)

Study group III

0.9% saline DRUG

patients will receive infused IV 0.9 % saline

group I

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20 - 60 years. Females of American Society of Anesthesiologists (ASA) class I or II physical status.
• Elective gynecological abdominal surgeries under intrathecal anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Yokoyama C, Mihara T, Kashiwagi S, Koga M, Goto T. Effects of intravenous dextrose on preventing postoperative nausea and vomiting: A systematic review and meta-analysis with trial sequential analysis. PLoS One. 2020 Apr 20;15(4):e0231958. doi: 10.1371/journal.pone.0231958. eCollection 2020.

  PMID: 32310996 BACKGROUND

• Kim HJ, Choi SH, Eum D, Kim SH. Is perioperative colloid infusion more effective than crystalloid in preventing postoperative nausea and vomiting?: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Feb;98(7):e14339. doi: 10.1097/MD.0000000000014339.

  PMID: 30762734 BACKGROUND

• Jewer JK, Wong MJ, Bird SJ, Habib AS, Parker R, George RB. Supplemental peri-operative intravenous crystalloids for postoperative nausea and vomiting: an abridged Cochrane systematic review. Anaesthesia. 2020 Feb;75(2):254-265. doi: 10.1111/anae.14857. Epub 2019 Sep 19.

  PMID: 31536172 BACKGROUND

• Wiesmann T, Kranke P, Eberhart L. Postoperative nausea and vomiting - a narrative review of pathophysiology, pharmacotherapy and clinical management strategies. Expert Opin Pharmacother. 2015 May;16(7):1069-77. doi: 10.1517/14656566.2015.1033398. Epub 2015 Apr 12.

  PMID: 25866213 BACKGROUND

• Metz A, Hebbard G. Nausea and vomiting in adults--a diagnostic approach. Aust Fam Physician. 2007 Sep;36(9):688-92.

  PMID: 17885699 BACKGROUND

• Balaban CD, Yates BJ. What is nausea? A historical analysis of changing views. Auton Neurosci. 2017 Jan;202:5-17. doi: 10.1016/j.autneu.2016.07.003. Epub 2016 Jul 16.

  PMID: 27450627 BACKGROUND

• Koju RB, Gurung BS, Dongol Y. Prophylactic administration of ondansetron in prevention of intrathecal morphine-induced pruritus and post-operative nausea and vomiting in patients undergoing caesarean section. BMC Anesthesiol. 2015 Feb 17;15:18. doi: 10.1186/1471-2253-15-18.

  PMID: 25971957 BACKGROUND

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Fareed Fathy Wadea Daneal, resident doctor

CONTACT

+2 01223814266; Fareed.16266190@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Anaesthesia, Intensive Care and Pain Management Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12