A clinical trial to compare dexmedetomidine or propofol with combination of scalp block on hemodynamic and postoperative recovery parameter in chronic subdural hematoma surgery

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/01/005478
• Date of registration: 30-01-2015
• Prospective Registration: No
• Primary sponsor: Apollo Hospitals Bilaspur CG India
• Public title: A clinical trial to compare dexmedetomidine or propofol with combination of scalp block on hemodynamic and postoperative recovery parameter in chronic subdural hematoma surgery
• Scientific title: Comparative evaluation of dexmedetomidine or propofol along with scalp block on haemodynamic and postoperative recovery for chronic subdural haematoma evacuation under monitored anaesthesia care
• Date of first enrolment: 01-12-2014
• Target sample size: 50
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10862
• Study type: Interventional
• Study design: Randomized, Parallel Group 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: Phase 4

Countries of recruitment

India

Contacts

• Name: Dr Vinit Kumar Srivastava
• Affiliation: Apollo Hospitals Bilaspur (C.G.) India

• Name: Dr Vinit Kumar Srivastava
• Affiliation: Apollo Hospitals Bilaspur (C.G.) India

Key inclusion & exclusion criteria

Inclusion criteria: 1. ASA grade I and III,

2. Scheduled for surgery under scalp block


Exclusion criteria: 1.Patients with known sensitivity to study drugs

2.Glasgow coma scale <12

3.history of drug or alcohol abuse,

4.history of chronic pain or daily intake of analgesics

5.Oral anticoagulant use (warfarin)

6.Patients with bleeding diathesis

7.impaired kidney or liver functions and

8.psychiatric patients

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Burr hole for chronic subdural hematoma patients

Intervention(s)

Intervention1: Propofol: Propofol loading dose 1mg/kg over 10 minutes, followed by maintenance infusion at a rate of 1-3 mg/kg/h
Control Intervention1: Dexmedetomidine: Dexmedetomidine loading dose 1 mcg/kg over 10 minutes, followed by maintenance infusion at a rate of 0.2-0.7 mcg/kg/h

Primary Outcome(s)

Hemodynamic parameter (blood pressure and heart rate) and oxygen saturaionTimepoint: Preop, After study drug, intraop period, postop period

Secondary Outcome(s)

Patient and Surgeon satisfaction, postoperative recovery parameterTimepoint: Postoperative period

Secondary ID(s)

NIL

Source(s) of Monetary Support

Apollo Hospitals Bilaspur

Ethics review

Status: Approved
Approval date: 01/12/2014
Contact:

Ethics Committee Apollo Hospitals Bilaspur