Opioid Sparing Anaesthesia for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery

Phase 4

Completed

• Conditions: PONV; Opioid Sparing Anaesthesia
• Interventions: Drug: Dexmedetomidine, ketamine and lidocaine; Drug: Normal saline

• Registration Number: NCT04706897
• Lead Sponsor: Tanta University

Brief Summary

In spite of multimodal analgesic strategies, which consist of opioids, dexamethasone, non-steroidal anti-inflammatory drugs, and local anesthetics applied into the surgical wound, postoperative pain and postoperative nausea and vomiting (PONV) are still common complaints reported after laparoscopic gynecological surgery.

So, it is hypothesized that the infusion consisting of lidocaine, dexmedetomidine and ketamine, as an opioid substitute was a feasible technique for laparoscopic gynecological surgery and would be associated with less incidence of PONV and lower opioid requirements in the early postoperative period.

The aim of this study was to evaluate the effect of opioid sparing technique via infusion of Dexmedetomidine, Ketamine and Lidocaine on post-operative nausea and vomiting in laparoscopic gynecological surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-10
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Study Start: 2021-01-15
• Status Verified: 2021-05
• Primary Completion: 2021-05-25
• Study Completion: 2021-05-26
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Patients scheduled for elective laparoscopic gynaecological surgery, who:

  • had the American Society of Anesthesiologists (ASA) I or II physical status,
  • were 21-60 years of age

Exclusion Criteria

• A body mass index >35 kg/ m2
• Pregnant, breast feeding women
• Hepatic, renal or cardiac insufficiency
• Diabetes mellitus
• History of chronic pain
• Alcohol or drug abuse
• Psychiatric disease
• Allergy or contraindication to any of the study drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine, ketamine and lidocaine (Study) group	Dexmedetomidine, ketamine and lidocaine	A loading infusion of syringe (B) containing the mixture was started at rate of 0.2 ml/kg/h ten minutes before induction. Then anesthesia was induced with 2 mg/kg IBW of propofol, patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (D) containing normal saline (as masking for fentanyl in the control group).
Normal saline (Control) group	Normal saline	A loading infusion of the 50 ml syringe (A) containing normal saline was started at rate of 0.2 ml/ kg/hr ten minutes before induction (as masking for mixture in group S). Then anesthesia was induced with 2 mg/kg ideal body weight (IBW) of propofol , patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (C) containing fentanyl (1 mic/kg of IBW).

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative nausea and vomiting (PONV)	First 24 hours postoperative	The total simplified PONV impact scale score ≥ 5

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	Intraoperative 3 hours
Intraoperative isoflurane consumption	Intraoperative 3 hours
Postoperative 24 hours morphine consumption.	First 24 hours postoperative	First 24 hr morphine consumption according to visual analogue sale (VAS). If VAS is more than 3, Intravenous morphine titration was administered as a bolus of 2 mg (body weight ≤60 kg) or 3 mg (body weight \>60 kg) with 5-minute lockout interval between each bolus repeated till pain is relieved.

Trial Locations

Locations (1)

Faculty of Medicine, Tanta University; 🇪🇬 Tanta, ElGharbiaa, Egypt