Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting

NCT ID: NCT06288542

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-05-01

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.

Conditions

Effect of Dextrose on Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

group c

control group . this group will not receive any iv fluids

Group Type: NO_INTERVENTION

No interventions assigned to this group

group d

Group D will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia

Group Type: EXPERIMENTAL

group d

Intervention Type: OTHER

this group will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia

group r

this group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia

Group Type: ACTIVE_COMPARATOR

group R

Intervention Type: OTHER

this group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia

Interventions

group d

this group will receive 1 mL/kg/h 5% Dextrose infusion, applied preoperatively during fasting until induction of anesthesia

Intervention Type: OTHER

group R

this group will receive 1 mL/kg/h ringer infusion, applied preoperatively during fasting until induction of anesthesia

Intervention Type: OTHER

Other Intervention Names

dextrose group; ringer group

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmin Hassab elnaby

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

yasmin yasmin hassabelnaby, assistant profesour

Role: CONTACT

yalnaby@yahoo.com

+201006719987

yasmin s hassabelnaby, assistant professor

Role: CONTACT

yalnaby@yahoo.com

Other Identifiers

MD-250-2022

Identifier Type: -

Identifier Source: org_study_id