checking the effect of fentanyl after giving two doses of injection dexmedetomidine before surgery in patients undergoing laparoscopic cholecystectomy

Not yet recruiting

• Conditions: Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,

• Registration Number: CTRI/2024/01/061310
• Lead Sponsor: Department of Anaesthesia and Intensive Care

Brief Summary

All the patients will be evaluated preoperatively for fitness a day before the surgery for the proposed surgical procedure under General Anaesthesia.. All enrolled patients will be kept fasting after midnight and will be pre-medicated with T. Alprazolam 0.25 mg and T. Pantoprazole 40 mg orally , a night before surgery and two hours before the surgery. The patient will be shifted to the operation room and will be monitored using multi-channel monitors. Group 1 (n=25) patients will be administered intravenous dexmedetomidine 0.5 μg.kg-1 in 100 ml normal saline over 15 minutes. Group 2 (n=25) patients will be administered intravenous dexmedetomidine 0.25 μg.kg-1 in 100 ml normal saline over 15 minutes. Group NS (n=25) patients will be administered  100 ml normal saline over 15 minutes. All the patients will be administered intravenous fentanyl 2 μg.kg-1 followed by pre oxygenation with 100 % oxygen for 3 minutes.. After induction and intubation Anaesthesia will be maintained with N2O and O2 in a ratio of 60:40 with sevoflurane and intermittent boluses of intravenous vecuronium 0.01 mg.kg-1 .. Tachycardia and hypertension (20% increase in HR and MAP respectively from their baseline values) will be corrected by a rescue dose of fentanyl 0.5 μg.kg-1. Fentanyl dose will be repeated after 10 minutes in case of unresolved tachycardia and hypertension. . All patients will receive intravenous paracetamol 1g 6 hourly for 24 hours postoperatively. In postoperative period patients will be assessed for pain by using VAS pain score for 24 hrs. Patients with VAS score ≥ 4 will receive a rescue analgesia of intravenous tramadol 2mg.kg-1.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-20
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1.ASA physical status I and II of either sex 2.Age between 18 to 65 years 3.BMI ≥20 to≤35 kg m2 4.Scheduled for laparoscopic cholecystectomy surgery.

Exclusion Criteria

• 1.Refusal by the patient 2.Patient with coagulopathy and bleeding disorder 3.Pregnant or lactating women 4.Contraindications or allergy to dexmedetomidine and fentanyl 5.Patient having hemodynamic instability.
• 6.Patients having pain in any area other than surgery site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total intraoperative rescue dose of fentanyl consumed.	0, 5, 15mins before induction, at the time of intubation and every 10 minutes after intubation till the end of surgery

Secondary Outcome Measures

Name	Time	Method
1.Haemodynamic response at 0, 5, 15mins before induction, at the time of intubation and every 10 minutes after intubation till the end of surgery.	2.Total induction dose of propofol consumed.

Trial Locations

Locations (1)

Government Medical College and Hospital; 🇮🇳 Chandigarh, CHANDIGARH, India

Government Medical College and Hospital

🇮🇳Chandigarh, CHANDIGARH, India

Dr Deepak Thapa

Principal investigator

9646121524

dpkthapa@gmail.com