To compare two doses of intravenous Dexmedetomidine in alleviating pain on propofol injection in patients undergoing elective surgery under general anaesthesia and to assess pain score

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/05/053174

Lead Sponsor: Pt. B.D. Sharma PGIMS Rohtak

Brief Summary: A prospective , randomized and double blinded study will be conducted in patients belonging to American society of anaesthesiology grade I and II between the age of 18-60 years of either sex and posted for elective surgery under general anaesthesia. All patients will be evaluated one day prior to surgery. Using random number table patients will be allocated to one of the two study groups comprising of 35 patients. Group A will receive an intravenous single dose of dexmedetomidine 0.2mcgkg-1 diluted with isotonic saline to a volume of 10ml to be given over 10 minutes. Group B will receive in intravenous single dose of dexmedetomidine 0.6mgkg-1 diluted with isotonic saline to a volume of 10ml to be given over 10 minutes. After 5 minutes induction will be done with injection propofol 2mgkg-1. The assessing anaesthesiologist will use a specially designed composite pain scale to evaluate the level of propofol injection pain. The pain score is based on assessment of patientsâ€™ motor and verbal reactions, from time of propofol injection to loss of consciousness. Pain graded on a 0-6 point scale, with a score >2 considered unacceptable. MAP and HR will be recorded immediately before injection of study drug , pre-induction, post-induction, pre-intubation and post-intubation. Complications such as bradycardia and hypotension will be recorded and treated accordingly.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Patients belonging to American society of Anaesthesiology grade I and II 2.
Age between 18-60 years 3.
Either sex 4.
Patients posted for elective surgery under general anaesthesia of duration 1-3hrs.

Exclusion Criteria

1.Patients with obesity (BMI>55kgm-2) 2.Patients with history of allergy to test drug 3.Patients with history of hepatic and renal dysfunction 4.Patients with history of psychological disorders 5.Patients with history of alcohol and drug abuse 6.Patients with Heart rate <55bpm 7.Refusal to participate in the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare and study the effectiveness of two doses of intravenous dexmedetomidine in alleviating pain on propofol injection. To note down changes in HR and MAP.	Assessment of patientsâ€™ motor and verbal reactions, from time of propofol injection to loss of consciousness. \| HR and MAP will be noted : 1.Immediately before injection of study drug \| 2.pre-induction \| 3.post-induction \| 4.pre-intubation \| 5.post-intubation.

Secondary Outcome Measures

Name	Time	Method
To note the side effects of intravenous dexmedetomidine if any.	To note the side effects of intravenous dexmedetomidine if any during the induction and intraoperatively

Trial Locations

Locations (1): Pt. B.D. Sharma, PGIMS, Rohtak
🇮🇳
Rohtak, HARYANA, India
Pt. B.D. Sharma, PGIMS, Rohtak
🇮🇳Rohtak, HARYANA, India
Dr Nandita Kad
Principal investigator
9896335544
kadnandita@gmail.com