study the effectiveness of dexmedetomidine, a drug,given before start of surgery by anesthetist, in preventing increase in blood pressure and pulse rate which generally occurs at that time and can result in dangerous arrhythmias and heart attack

Phase 4

Completed

• Conditions: surgery under general anesthesia

• Registration Number: CTRI/2011/10/002046
• Lead Sponsor: Swai Maan singh Medical College and Attached hospital

Brief Summary

Conventional laryngoscopy and endotacheal intubation cause significant changes in hemodynamics of patients i.e. increase in heart rate and blood pressure and precipitate arrhythmias which may lead to ischemia and myocardial infarction. In present study dexmedetomidine will be used in combination with fentanyl to attenuate this response.  The aim of study is to study the effect of dexmedetomidine over and above fentanyl in attenuating the hemodynamic response to laryngoscopy and intubation.

In this prospective randomized double blind placebo controlled trial 100 patients will be selected and divided into 2 groups of 50 each. Baseline parameters like body weight , pulse rate and blood pressure will be recorded. Inj.glycopyrolate and inj. fentanyl will be given as premedication. Test drug ( dexmedetomidine/ placebo) will be given by infusion in a double blind fashion. Rate of infusion is adjusted according to body weight. Induction of anesthesia is done with inj. propofol (2mg/kg) and inj. rocuronium (0.8 mg/kg).  laryngoscopy and intubation is done 120 seconds after induction. Blood pressure pulse rate oxgen saturation is recorded at 5, 10, 13 ( just before intubation)   , 14 ( just after intubation), 15, 18, 20 , 25 min after start of infusion. Any intraoperative complication will be noted.Patient will then be extubated at end of procedure after the onset of spontaneous respiration. Statistical anaylsis will be done  using various tests like student-t-test and results and conclusion will be made.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-10
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Patients with ASA grade 1 and 2 2.Patients of age group 18 to 55 years of either sex undergoing surgery under general anesthesia 3.Patients willing to give written and informed consent.

Exclusion Criteria

1.Patients refusal 2.Major organ dysfunction 3.Patients on medications like hypnotics, narcotic analgesics, α2 agonists, calcium channel blockers, β blockers 4.Patients with anticipated difficult intubation 5.Patients intubated after more than 1 attempt or more than 20 seconds 6.Patients with impaired LFT/RFT 7.Patients with ASA grade 3, 4, 5 8.Deaf and dumb patients 9.Patients with respiratory and cardiac disease 10.Patients having known allergy to anesthetic agents used in study 11.Psychiatric patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in systolic, diastolic and mean blood pressure, pulse rate, oxgen saturation compared to baseline at various points before and after intubation compared to baseline	5 , 10 ,13,14(just after intubation),15,18,20,25 min after start of drug infusioon and baseline parameters

Secondary Outcome Measures

Name	Time	Method
complications like bradycardia , hypotention etc	intraoperative( time period may vary and immediate post operative till 10 min after extubation

Trial Locations

Locations (1)

Swai Maan Singh Medical college And Hospital, JAIPUR; 🇮🇳 Jaipur, RAJASTHAN, India

Swai Maan Singh Medical college And Hospital, JAIPUR

🇮🇳Jaipur, RAJASTHAN, India

Rishabh Kumar

Principal investigator

09694580547

cool_rishu@hotmail.com