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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04706897
Enrollment
80
Registered
2021-01-13
Start date
2021-01-15
Completion date
2021-05-26
Last updated
2021-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Sparing Anaesthesia, PONV

Keywords

Laparoscopic Gynecological Surgery, Dexmedetomidine, Ketamine, Lidocaine, PONV

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.

Interventions

DRUGDexmedetomidine, 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).

DRUGNormal 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).

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative nausea and vomiting (PONV)First 24 hours postoperativeThe total simplified PONV impact scale score ≥ 5

Secondary

MeasureTime frameDescription
Intraoperative isoflurane consumptionIntraoperative 3 hours
Intraoperative fentanyl consumptionIntraoperative 3 hours
Postoperative 24 hours morphine consumption.First 24 hours postoperativeFirst 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026