Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting

Not Applicable

Not yet recruiting

• Conditions: Effect of Dextrose on Postoperative Nausea and Vomiting

• Registration Number: NCT06288542
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-02-25
• Last Update Submitted: 2024-02-25
• Study Start: 2024-03-01
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 111

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
TOTAL AMOUNT OF ANTIEMETIC REQUIRED	From end of surgery to 24 hours postoperative