search
Back to results

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

Primary Purpose

PONV, Opioid Sparing Anaesthesia

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine, ketamine and lidocaine
Normal saline
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PONV focused on measuring Laparoscopic Gynecological Surgery, Dexmedetomidine, Ketamine, Lidocaine, PONV

Eligibility Criteria

21 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine, Tanta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Normal saline (Control) group

Dexmedetomidine, ketamine and lidocaine (Study) group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

The incidence of postoperative nausea and vomiting (PONV)
The total simplified PONV impact scale score ≥ 5

Secondary Outcome Measures

Intraoperative isoflurane consumption
Intraoperative fentanyl consumption
Postoperative 24 hours morphine consumption.
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.

Full Information

First Posted
January 10, 2021
Last Updated
May 26, 2021
Sponsor
Tanta University
search

1. Study Identification

Unique Protocol Identification Number
NCT04706897
Brief Title
Opioid Sparing Anaesthesia for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery
Official Title
Opioid Sparing Anaesthesia Via Dexmedetomidine, Ketamine and Lidocaine Infusion for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PONV, Opioid Sparing Anaesthesia
Keywords
Laparoscopic Gynecological Surgery, Dexmedetomidine, Ketamine, Lidocaine, PONV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline (Control) group
Arm Type
Sham Comparator
Arm Description
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).
Arm Title
Dexmedetomidine, ketamine and lidocaine (Study) group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine, ketamine and lidocaine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
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).
Primary Outcome Measure Information:
Title
The incidence of postoperative nausea and vomiting (PONV)
Description
The total simplified PONV impact scale score ≥ 5
Time Frame
First 24 hours postoperative
Secondary Outcome Measure Information:
Title
Intraoperative isoflurane consumption
Time Frame
Intraoperative 3 hours
Title
Intraoperative fentanyl consumption
Time Frame
Intraoperative 3 hours
Title
Postoperative 24 hours morphine consumption.
Description
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.
Time Frame
First 24 hours postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Laparoscopic Gynecological Surgery
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine, Tanta University
City
Tanta
State/Province
ElGharbiaa
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be shared with a reasonable request from the corresponding author

Learn more about this trial

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

We'll reach out to this number within 24 hrs