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

May 26, 2021 updated by: Aya Ibrahim Moustafa, Tanta University

Opioid Sparing Anaesthesia Via Dexmedetomidine, Ketamine and Lidocaine Infusion for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • ElGharbiaa
      • Tanta, ElGharbiaa, Egypt, 31527
        • Faculty of medicine, Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Normal saline (Control) group
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
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).
EXPERIMENTAL: Dexmedetomidine, ketamine and lidocaine (Study) group
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative nausea and vomiting (PONV)
Time Frame: First 24 hours postoperative
The total simplified PONV impact scale score ≥ 5
First 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative isoflurane consumption
Time Frame: Intraoperative 3 hours
Intraoperative 3 hours
Intraoperative fentanyl consumption
Time Frame: Intraoperative 3 hours
Intraoperative 3 hours
Postoperative 24 hours morphine consumption.
Time Frame: 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.
First 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2021

Primary Completion (ACTUAL)

May 25, 2021

Study Completion (ACTUAL)

May 26, 2021

Study Registration Dates

First Submitted

January 10, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (ACTUAL)

January 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 26, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33362/9/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data can be shared with a reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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