Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia

NCT04525274 | Completed

• 1 other identifier: 20-7-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

sleeve gastrectomy; postoperative analgesia; intraperitoneal dexmedetomidine; intraperitoneal ketamine

Outcome Measures

Primary Outcomes (1)

• change in assessment of postoperative shoulder, abdominal and incisional pain

  will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.

  at 1, 2, 4, 6, 12 and 24 hours postoperatively

Secondary Outcomes (3)

• Time of first request of analgesia

  within 24 hour postoperative

• Total rescue analgesic requirement

  during the first postoperative 24 hours

• The incidence of postoperative nausea and vomiting (PONV)

  during the first postoperative 24 hours

Study Arms (3)

control group

PLACEBO COMPARATOR

patient will receive 40 ml bupivacaine 0.25% + 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.

Drug: normal saline

dexmedetomidine group

ACTIVE COMPARATOR

patient will receive 40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.

Drug: dexmedetomidine

ketamine group

ACTIVE COMPARATOR

patient will receive 40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.

Drug: Ketamine

Interventions

normal saline DRUG

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.

control group

dexmedetomidine DRUG

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.

dexmedetomidine group

Ketamine DRUG

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.

ketamine group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance.
• Age 21-60 years old.
• Sex both male and female.
• BMI ≥40 kg/m2
• ASA II and ASA III.
• Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.

You may not qualify if:

• Patients with known history of allergy to study drugs.
• Patients with uncontrolled diabetes mellitus.
• Psychological and mental disorders.
• Severe hypertensive, cardiac, hepatic and renal patients.
• Patients on opioid or sedative use.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

faculty of medicine, Zagazig university

Zagazig, Elsharqya, 44519, Egypt

Location

Related Publications (5)

• Ozkan AS. Anesthesia management in sleeve gastrectomy: Single center experience. Annals of Medical Research. 2018; 25(4)613-8.

  RESULT

• Tekeli AE, Eker E, Bartin MK, Oner MO. Anesthesia Management in Laparoscopic Sleeve Gastrectomy Cases. East J Med. 2019; 24(3): 335-9.

  RESULT

• Praveena BL, Bharathi B, Sahana VR. Intraperitoneal Ropivacaine with Dexmedetomidine or Fentanyl for Postoperative Analgesia Following Laparoscopic Cholecystectomy: A Comparative Randomized Trial. Anesth Essays Res. 2019 Jan-Mar;13(1):169-173. doi: 10.4103/aer.AER_191_18.

  PMID: 31031500 RESULT

• Beder El Baz MM, Farahat TEM. Intraperitoneal Levobupivacaine Alone or with Dexmedetomidine for Postoperative Analgesia after Laparoscopic Cholecystectomy. Anesth Essays Res. 2018 Apr-Jun;12(2):355-358. doi: 10.4103/aer.AER_205_17.

  PMID: 29962597 RESULT

• EL-Gaby SS, Mohammed SS. Intraperitoneal ketamine attenuates the inflammatory reactivity associated with pneumoperitoneum. Research and Opinion in Anesthesia & Intensive Care. 2017; 4:149-55.

  RESULT

MeSH Terms

Conditions

Obesity

Interventions

Saline Solution; Dexmedetomidine; Ketamine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: triple blinded (patient, surgeon and outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care

Model Details: The patients will be divided randomly by a computer-generated randomization table into three equal groups

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 25, 2020
• Study Start: October 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 20, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator

Locations

EG (1)