" To compare the efficacy and safety of tramadol and dexmedetomidine in control of post spinal shivering."

â??A Comparative Study of Dexmedetomidine and Tramadol for prevention of post-spinal anaesthesia shivering .â??

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/023040

Enrollment

120

Registered

2020-01-30

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: J99- Respiratory disorders in diseasesclassified elsewhere

Interventions

Intervention1: â?? Tramadol for prevention of post-spinal anaesthesia shivering .â??: A uses of Tramadol(0.5mg/kg) for prevention of post-spinal anaesthesia (10min before give spinal anesthesia)shive

Eligibility

Inclusion criteria

Inclusion criteria: Informed written consent for participation in study. Age: 18 to 65 years. Gender: Either gender. Patients with haemodynamic HR >60/min , SBP >100 mmHg , after atleast 15 minutes of administering spinal anaesthesia . Patients scheduled for elective lower abdominal, lower limb, gynaecological procedures as well as caesarean section , orthopedics and plastic surgeries under spinal anaesthesia included in the study . ASA physical status I ,II & III.

Exclusion criteria

Exclusion criteria: Patients with known hypersensitivity to dexmedetomidine or tramadol . ASA physical status IV and above. History of drug allergy (local anaesthetics). Patients on anticoagulants. History of bleeding disorders. Psychiatric illness &Uncooperative patients. Any major systemic illness like hypertension, heart block etc. Patients with cardio pulmonary , renal and hepatic disease .

Design outcomes

Primary

Measure	Time frame
Time of onset of shivering (10 minutes intervals) , after given spinal anesthesia Severity of shivering â?¢ Time to disappearance of shivering (s) â?¢ Time of recurrence (min) Timepoint: Time of onset of shivering (10minutes intervals) , after given spinal anesthesia Severity(grading) of shivering â?¢ Time to disappearance of shivering (minute) â?¢ Time of recurrence (min)	—

Secondary

Measure	Time frame
Duration of surgery (min) Duration of spinal anaesthesia (min) â?¢ Comparison of shivering grade of both groups â?¢ Comparison of sedation score of both groups â?¢ Intraoperative monitoring parameter in term of Heart rate, Mean arterial pressure, spo2 â?¢ Surgeonâ??s satisfaction score. â?¢ Patientâ??s satisfaction score.Timepoint: 12 month	—

Countries

India

Contacts

Public ContactDr Komal Shah

GMC Bhavnagar

shah.komal@rediffmail.com9427215252

Outcome results

None listed

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