Comparing the effect of clonidine and pregabalin in reducing heart rate and blood pressure while placement of tube in windpipe during surgery for gall bladder removal.
- Conditions
- Patients undergoing elective Laparoscopic Cholecystectomy.ASA I and II.Age between 18 to 65 years.Patients of Either Sex.
- Registration Number
- CTRI/2018/06/014675
- Lead Sponsor
- Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi
- Brief Summary
The present study is designed to compare the efficacy of oral pregabalin vs clonidine for attenuation of haemodynamic response to laryngoscopy and tracheal intubation in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Haemodynamic changes (HR, SBP, DBP, MAP) following laryngoscopy and intubation will be recorded and compared between the groups. The study is conducted in 80 patients aged 18-65 years with ASA grade 1 or 2 of both gender admitted in VMMC and Safdarjung hospital. patients are divided into two groups, group P - pregabalin and group C - clonidine. patient in group P will receive 75mg oral pregabalin tablet and in group C will receive 200mcg clonidine tablet 90 minutes before surgery with sip of water. A detailed preanaesthetic evaluation including all routine investigations as guide by age will be carried out in all patients. Patients excluded from the study are:
1-anticipated difficult airway.
2-subjects with BMI>30.
3-patients concomitantly on clonidine or pregabalin or consumption of antihypertensive drugs, sedatives or hypnotics.
4-patients with history of cardiovascular, cerebrovascular, neurological and respiratory, renal and hepatic dysfunction.
5-patients with history of allergic reaction to any of the study drugs.
In OT, standard monitoring including Spo2, NIBP, ECG, HR and sedation level will also be noted. patient will be given fentanyl 2mcg/kg IV and after 3-5 minutes induced with propofol 2-2.5mg/kg IV followed by injection Vecuronium 0.1mg/kg, IPPV with N2O with O2 with isoflurane 0.6% at flow rate of 6L/min, 3 minutes later laryngoscopy and intubation will be performed. haemodynamic parameters will be noted before induction, immediately after induction, 3 minutes after induction and 1,3,5 and 10 minutes after intubation. Anesthesia will be maintained with 66% N2O with O2 and isoflurane 0.6%. At the end of surgery, inhalational anaesthetic agent will be stopped, neuromuscular blockade reversed with inj glycopyrolate 0.01mg/kg and inj neostigmine 0.05mg/kg and trachea extubated. patient will be shifted to postoperative care unit when fully conscious and vitals stable.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 80
- Undergoing elective Laparoscopic cholecystectomy.
- ASA I and II.
- Anticipated difficult intubation.
- BMI more than 30.
- Patient concomitantly on Clonidine or Pregabalin or on Anti hypertensive drugs, Sedatives or hypnotics.
- Patients with history of cardiovascular , cerebrovascular, neurological and respiratory disease, renal and hepatic dysfunction.
- Patients with history of allergic reactions to any of the study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of oral pregabalin and Clonidine in attenuating the hemodynamic responses to laryngoscopy and intubation. Before premedication (T0). | Preinduction (TPREI). | Immediately after induction (TP0I). | 3 minute after induction (TP0I3). | 1(TT1), 3(TT3), 5(TT5) and 10(TT10) minutes after intubation
- Secondary Outcome Measures
Name Time Method to compare the efficacy of Oral pregabalin and clonidine in attenuating the hemodynamic responses to laryngoscopy and intubation Before premedication.
Trial Locations
- Locations (1)
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi - 110029
🇮🇳Delhi, DELHI, India
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi - 110029🇮🇳Delhi, DELHI, IndiaDr Rajneesh ChoudharyPrincipal investigator9716930584rajneesh.choudharypg@gmail.com