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A clinical trial to study the role of dexmedetomidine to control shivering after operation of head.

Role of Dexmedetomidine in Preventing Post-operative Shivering Following Craniotomy: a Randomized Placebo-controlled Double-blind Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/012921
Enrollment
56
Registered
2018-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients undergoing craniotomy

Interventions

Intervention1: infusion dexmedetomidine: Intravenous infusion dexmedetomidine-0.7 µg /kg/ hr was started 10 minutes before induction of anaesthesia of each patient and was continued throughout the s

Sponsors

Bangur Institute of Neurosciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Written informed consent of the patients. 2)ASA grade I and II. 3)Age between 18 â?? 60 years. 4)Patients of either sex. 5)Patients scheduled for craniotomy operations who are supposed to be operated within 3 hours.

Exclusion criteria

Exclusion criteria: 1)Patientsâ?? refusal. 2)ASA grade III and IV. 3)Patients allergic to study medications. 4)Patientsâ?? with thyroid disorder, Parkinsons disease, dysautonomia, Raynaudâ??s syndrome, cardiopulmonary disease, history of allergy to drugs used, history of chronic use of sedative and hypnotic drugs. i)History of conduction defect of heart. ii)Initial core temperature >37.5oC or iii)Obese patients with B.M.I >30. iv)Pregnant or lactating women. v)Renal or hepatic dysfunction.

Design outcomes

Primary

MeasureTime frame
Number of patients suffered from post-operative shivering in each group.Timepoint: first 6 hr postoperative

Secondary

MeasureTime frame
1)Number of patients required rescue drug for shivering in the post-operative period. 2)postoperative sedation 3)intra operative blood pressure and heart rate 4)any side effects like hypotension,bradycardia,nausea postoperativelyTimepoint: first 6 hr postoperative

Countries

India

Contacts

Public ContactSaikat Niyogi

IPGMER

saikatneuro1972@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026