THE EFFECT OF DEXMEDETOMIDINE ON ANAESTHETIC REQUIREMENT, HEMODYNAMIC VARIABLES AND POST OPERATIVE PAIN RELIEF IN CERVICAL SPINE SURGERY

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/11/006352
• Date of registration: 09-11-2015
• Prospective Registration: No
• Primary sponsor: PGIMER Chandigarh
• Public title: THE EFFECT OF DEXMEDETOMIDINE ON ANAESTHETIC REQUIREMENT, HEMODYNAMIC VARIABLES AND POST OPERATIVE PAIN RELIEF IN CERVICAL SPINE SURGERY
• Scientific title: THE EFFECT OF INTRAVENOUS DEXMEDETOMIDINE ON ANAESTHETIC REQUIREMENT, HEMODYNAMIC VARIABLES AND POST OPERATIVE ANALGESIA IN CERVICAL SPINE SURGERY
• Date of first enrolment: 01-10-2010
• Target sample size: 60
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9707
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Panda Nidhi Bidyut
• Affiliation: Department of Anesthesia and Intensive Care

• Name: Amutha V
• Affiliation: Department of Anesthesia and Intensive Care

Key inclusion & exclusion criteria

Inclusion criteria: 60 ASA I-II patients, aged between 18-60 years undergoing elective cervical spine surgery (Cervical discectomy with or without fusion)
Exclusion criteria: i. ASA III-IV patients

ii. Pregnancy or breast feeding patient

iii. Patients planned for elective post-operative mechanical ventilation

iv. morbidly obese (BMI > 40)

v. patients with drug or alcohol abuse

vi. concurrent use of α2 agonist

vii. patients with history of heart block

viii. patients on β blockers/ HR <60/min



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- ADULT PATIENTS (18-60 YRS OLD) UNDERGOING CERVICAL SPINE SURGERY

Intervention(s)

Intervention1: dexmedetomidine: Patients in this group to receive bolus of dexmedetomidine 1µg/ kg as iv infusion over 10 minutes followed by dexmedetomidine infusion at a rate of 0.5 µg/ kg/ hr till the end of the surgery. to start dexmedetomidine infusion at a rate of 0.2 µg/ kg/ hr in the postoperative period after shifting patient to Post anaesthesia care unit and to continue till 24 hours postoperative period.
Control Intervention1: normal saline: volume matched infusion as placebo

Primary Outcome(s)

â?¢Intra- operative anaesthetic drug requirement

â?¢Intra- operative haemodynamic parameter

â?¢Recovery from anaesthesia

â?¢Post operative analgesic requirement

Timepoint: intraoperative and postoperative till 48 hrs

Secondary Outcome(s)

ADVERSE EFFECTS IF ANYTimepoint: INTRAOPERATIVE AND POSTOPERATIVE TILL 48 HRS

Secondary ID(s)

MS/1262/MS/8100

Source(s) of Monetary Support

DEPARTMENT OF ANAESTHESIA, PGIMER, CHANDHIGARH

Ethics review

Status: Approved
Approval date: 22/09/2010
Contact:

ETHICS REVIEW COMMITTEEE, PGIMER, CHANDIGARH