Effect of intraperitoneal dexmedetomidine versus intravenous dexmedetomidine on recovery profile and inflammatory response following laparoscopic cholecystectomy : a randomized comparative study
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Comparison of time for extubation in the two groups.
Study Overview
Brief Summary
Patient will be taken to OT and vital monitoring systems attached, routine steps of general anaesthesia followed.
An 18G iv cannula will be inserted blood sample collected for a baseline evaluation of biochemical markers included in the study objectives.
During gall bladder resection, the IV group receives Dexmedetomidine (0.7µg/kg) infusion, while the IP group receives normal saline alone, for 10 minutes.
Post-resection, the IV group receives 40ml 0.2% Ropivacaine, while the IP group receives a 40ml mixture of Dexmedetomidine (0.7µg/kg) with 0.2% Ropivacaine.
10 ml of this solution will be given on either side into the subdiaphragmatic space in a fan shaped manner by the surgeon. The remaining solution will be instilled in the gall bladder bed.
Modified Aldrete scoring with a score of ≥9 will be used as a criteria to discharge the patient from PACU.
Postoperative pain will be assessed using the NRS immediate post operatively and then at 30 min, 1 h, 2h, 6h, 12 h and 24 h postoperatively. In patients with NRS >4, a bolus dose of Tramadol 50 mg intravenous (not to be repeated before 8 hours) will be administered as rescue analgesia along with Ondansetron 0.1 mg/kg to prevent emesis.
Time to demand of first rescue analgesic and its total consumption in 24 hours will be noted.
At 6 hours post induction, blood sample will be sent for evaluation of biochemical markers along with the routine post operative investigations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Consenting male or female patients aged 18-60 years scheduled for elective Laparoscopic cholecystectomy under general anaesthesia.
- •Belonging to ASA grade I or II.
Exclusion Criteria
- •Patients with abnormalities like heart block, conduction defect in pre-operative ECG
- •Patients with known allergies to the study drugs
- •Obese patients (BMI ≥ 30)
- •Patients in whom subhepatic drain is inserted after gall bladder removal.
Outcomes
Primary Outcomes
Comparison of time for extubation in the two groups.
Time Frame: Time taken from administration of reversal drug to removal of endotracheal tube
Secondary Outcomes
- To compare between the two groups various inflammatory markers such as:-(i) IL-6)
- To compare between the two groups –(1.Time to discharge from PACU using Modified Aldrete score. 2. Hemodynamic parameters at the time of extubation)
- To compare between the two groups –(Amount of rescue analgesia required in 24 hours)
Investigators
Dr Ruchi Kapoor
University College of Medical Sciences and Guru Teg Bahadur hospital