Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting

The Relationship of Preoperative Intravenous Dextrose Infusion to Postoperative Nausea and Vomiting in Gynecological Laparoscopic and Hysteroscopic Surgeries: A Randomized Control Trial

This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures

Study Overview

• Status: Not yet recruiting
• Conditions: Effect of Dextrose on Postoperative Nausea and Vomiting
• Intervention / Treatment: Other: group d; Other: group R

Detailed Description

A history of PONV risk factors will be recorded. After consenting, patients will be assigned using a computerized randomization function to Ringer solution (group R) or 5% dextrose (group D) or control group (group C). Group D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia. Group R will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia. Group C will receive no fluids. The anesthesia providers, surgeons, perioperative nurses, postanesthesia care unit (PACU) nurses and investigators will be blinded to group assignment throughout.

As for pre-medication, all patients will receive IV midazolam (0.02 mg/kg). Anesthesia will be induced with propofol (1.5-2 mg/kg), fentanyl (1-2 μg/kg) and atracurium(o.5mg/kg) to facilitate endotracheal intubation. The lungs will be mechanically ventilated and anesthesia will be maintained with isoflurane in O2/air. Intraoperative IV maintenance fluid will be standardized at 3 mL/kg/h with additional IV crystalloid given as needed at the discretion of the anesthesia provider if arterial blood pressure decreased >20% from baseline. For postoperative pain relief, paracetamol 1 g will be given I.V. during surgery in all patients and continued orally after operation (1g every 6 h). In addition, all patients will be ambulated within 6 h after completion of surgery. Standardized antiemetic and analgesic rescue medications will be available. Patients will receive no rescue antiemetic medication when the VRS score is 0 to 2; 1 dose of rescue medication when the VRS score is 3 to 6; and ≥2 doses for nausea score of 7 to 10, to reduce the nausea score to 0 to 2.

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yasmin yasmin hassabelnaby, assistant profesour; Phone Number: +201006719987; Email: yalnaby@yahoo.com
• Study Contact Backup: Name: yasmin s hassabelnaby, assistant professor; Email: yalnaby@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult female patients scheduled for elective laparoscopic gynecological/hysteroscopic procedures will be considered for inclusion
• ASA physical status I and ll.

Exclusion Criteria:

• patients with a previous history of PONV.
• Patients with motion sickness, coagulopathy, diabetes mellitus, or severe hypertension
• patients with cardiac, renal or hepatic dysfunction.
• patients receiving an antiemetic agent within 24 h before surgery or cases where complications occurs during the surgery
• patients who have abnormal blood glucose on the night before surgery
• patients who are unable to understand and use the verbal rating scale (VRS);Growth developmental, and motor-mental retardation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: group c; control group . this group will not receive any iv fluids
Experimental: group d; Group D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia	Other: group d; this group will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia; Other Names: dextrose group
Active Comparator: group r; this group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia	Other: group R; this group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia; Other Names: ringer group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of post-opertive nausea and vomiting in 24 hour	using verbal rating scale (VRS)	FROM ENROLLMENT TO 24 HOURS AFTER SURGERY

Secondary Outcome Measures

Outcome Measure	Time Frame
TOTAL AMOUNT OF ANTIEMETIC REQUIRED	From end of surgery to 24 hours postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: postoperative nausea and vomiting; dextrose infusion; gynecological laparoscope and hysteroscope
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: MD-250-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No