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

NCT04706897 | Completed Phase 4

• 1 other identifier: 33362/9/19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

PONV; Opioid Sparing Anaesthesia

Keywords

Laparoscopic Gynecological Surgery; Dexmedetomidine; Ketamine; Lidocaine; PONV

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative nausea and vomiting (PONV)

  The total simplified PONV impact scale score ≥ 5

  First 24 hours postoperative

Secondary Outcomes (3)

• Intraoperative isoflurane consumption

  Intraoperative 3 hours

• Intraoperative fentanyl consumption

  Intraoperative 3 hours

• Postoperative 24 hours morphine consumption.

  First 24 hours postoperative

Study Arms (2)

Normal saline (Control) group

SHAM COMPARATOR

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).

Drug: Normal saline

Dexmedetomidine, ketamine and lidocaine (Study) group

EXPERIMENTAL

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).

Drug: Dexmedetomidine, ketamine and lidocaine

Interventions

Dexmedetomidine, ketamine and lidocaine DRUG

A loading infusion of syringe (B) containing the a mixture \[dexmedetomidine (2 µg/ml), ketamine (0.5 mg /ml) and lidocaine (4 mg /ml)\] 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).

Dexmedetomidine, ketamine and lidocaine (Study) group

Normal saline DRUG

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 (1mic/kg of IBW).

Normal saline (Control) group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Gender Eligibility Details: Laparoscopic Gynecological Surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Tanta University

Tanta, ElGharbiaa, 31527, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexmedetomidine; Ketamine; Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 13, 2021
• Study Start: January 15, 2021
• Primary Completion: May 25, 2021
• Study Completion: May 26, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)