Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting

Cairo University (CU)

Status: Not yet enrolling

Conditions: Effect of Dextrose on Postoperative Nausea and Vomiting

Treatments: Other: group d; Other: group R

Study type: Interventional

Funder types: Other

Identifiers

NCT06288542

MD-250-2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 111 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 3 patient groups

group c

No Intervention group

Description:

control group . this group will not receive any iv fluids

group d

Experimental group

Description:

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

Treatment:

Other: group d

group r

Active Comparator group

Description:

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

Treatment:

Other: group R