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Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia

NCT04525274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-27

No results posted yet for this study

Summary

Post-laparoscopic sleeve pain management is essential for early mobilization of the patient and so on decrease post-operative complication. The use of opioids is associated with adverse effects such as nausea, pruritus, sedation, and occasionally respiratory depression.

Previous studies stated that intraperitoneal instillation of bupivacaine alone has been used to reduce acute postoperative abdominal and shoulder pain allow early mobilization and decrease postoperative opioid requirements and its complications.

In this study the investigators will compare between intraperitoneal instillation of dexmedetomidine with bupivacaine versus ketamine with bupivacaine in patients undergoing laparoscopic sleeve gastrectomy under general anesthesia regarding to postoperative pain relief to reduce morbidity and mortality.

Conditions

Interventions

DRUG

normal saline

At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of 40 ml bupivacaine 0.25% + 5 ml normal saline will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon. The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure.

DRUG

dexmedetomidine

At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon. The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure.

DRUG

Ketamine

At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon. The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-04-30
Completion
2022-05-20

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04525274 on ClinicalTrials.gov