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Comparison of two intravenous dosages of Dexmedetomidine(0.5 mcg/kg and 0.3 mcg/kg body weight) as antishivering agent following spinal anaesthesia in adults

A study to compare two different intravenous dosages of Dexmedetomidine as an anti-shivering agent following spinal anaesthesia in adults.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083341
Enrollment
98
Registered
2025-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: M968- Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Dexmedetomidine as anti-shivering agent post spinal Anaesthesia.: To determine the incidence of successful recovery from shivering in post spinal anaesthesia patients along with time ta

Sponsors

Department of Anaesthesiology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 65 years. 2. Physical status 1 and 2 according to American Society of Anaesthesiologists (ASA). 3. Have undergone spinal anaesthesia and having Grade 3 AND Grade 4 shivering post spinal anaesthesia. 4. Amount of fluid to be given is as co-loading 10ml/Kg bodyweight and as maintenance as per the need to maintain the hemodynamic status of the patient. 5. Duration of surgery not more than 120 minutes.

Exclusion criteria

Exclusion criteria: 1. Patients who are unwilling to participate. 2. Patients with significant cardiac, pulmonary, hepatic or renal diseases. 3. Abnormal coagulation profile. 4. Spinal deformities. 5. Evidences of skin infection at the site of injection. 6. Disabling neuropsychiatric disorder. 7. Known hypersensitivity to Dexmedetomidine. 8. Anticipated difficult intubation. 9. Chronic drug abusers and alcoholics. 10. Surgery converted to general anaesthesia.

Design outcomes

Primary

MeasureTime frame
1. Number of patients with complete response(shivering grade less than 2) 2. Efficacy of shivering control, assessed by the Time to cease shivering following the different doses of study drug administration and comparing them.Timepoint: 1. Number of patients with complete response(shivering grade less than 2) 2. Efficacy of shivering control, assessed by the Time to cease shivering following the different doses of study drug administration and comparing them.

Secondary

MeasureTime frame
1. Shivering scores between the different groups, recorded at various time intervals. 2. Compare the systolic blood pressure, diastolic blood pressure, heart rate at different intervals before & after drug administrations. 3. Ramsay sedation scale will be assessed in all patients at 0, 5, 15, 30, 60, 120 minutes post dosage. 4. Any adverse events like nausea, vomiting, palpitation, excessive sedation etc. will be recorded & compared between groups.Timepoint: 0 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes.

Countries

India

Contacts

Public ContactDr Amit Kumar Ray

Institute of post graduate medical education and research

raymit2005@gmail.com9830374904

Outcome results

None listed

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