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

PONV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706897
• Other study ID #: 33362/9/19
• Status: Completed
• Phase: Phase 4
• Start date: January 15, 2021
• Est. completion date: May 26, 2021

Study information

• Verified date: May 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 26, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Sparing Anaesthesia
• PONV
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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).
• 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).

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Tanta University	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative nausea and vomiting (PONV)	The total simplified PONV impact scale score = 5	First 24 hours postoperative
Secondary	Intraoperative isoflurane consumption		Intraoperative 3 hours
Secondary	Intraoperative fentanyl consumption		Intraoperative 3 hours
Secondary	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.	First 24 hours postoperative