A clinical trial to study the effects of two drugs,Dexmedetomidine and Fentanyl during pneumoperitonium in laproscopic cholecystectomy.

Completed

• Conditions: Calculus of gallbladder with acutecholecystitis,

• Registration Number: CTRI/2019/07/019958
• Lead Sponsor: Department of Anaesthesiology Medical CollegeJaipur

Brief Summary

Dexmedetomidine is a highily selective alpha2 agonist that provides anxiolysis,analgesia and cooperative sedation without respiratory depression.Fentanyl is a potent synthetic mu receptor opoid agonist that produces dose dependent analgesia and sedation. In this study we aim to compare the effectiveness of inj.Dexmedetomidine Vs inj.Fentanyl  for attenuation of hemodynamic response to pneumoperitonium in laproscopic cholecystectomy.We hypothesize that Dexmedetomine would be better  in controlling haemodynamic parameters and pain then in Fentanyl.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-02-12
• Study Start: 2019-10-07
• Last Update Posted: 2019-12-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 1.Patients with ASA grade I and II 2.Patients willing to give written informed consent.
• 3.Age Groups 18 to 50 years 4.Weighing 40 to 70 kg.
• 5.Scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria

1.Patients not willing to participate in study 2.Patients having history of allergy to anaesthestic agents used in study 3.Patients with pre-existing cardiac disease, Hypertension ,Asthama,Renal or Hepatic dysfunction 4.Patients with anticipated difficult intubation i.e Mallampati class 3 or more,restricted neck movement or restricted mouth opening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the change in hemodynamic variables (HR,SBP,DBP,MAP) after pneumoperitoneum in both the study groups.	Data will be recorded Just Before induction,1min after induction,1 min after intubation,3min after intubation,1min after PNP and 10min interval in PNP throughout the surgery and after extubation

Secondary Outcome Measures

Name	Time	Method
1. To assess and compare the duration of post operative analgesia in both the study groups.	2. To determine post-operative sedation level in both the study groups.

Trial Locations

Locations (1)

SMS MEDICAL COLLEGE,Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

SMS MEDICAL COLLEGE,Jaipur

🇮🇳Jaipur, RAJASTHAN, India

DR REEMA MEENA

Principal investigator

9413237117

reemadrrn@gmail.com