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

Phase 4

Not yet recruiting

• Conditions: Respiratory disorders in diseasesclassified elsewhere,

• Registration Number: CTRI/2020/01/023040
• Lead Sponsor: Goverment medical college bhavnagar

Brief Summary

- Dexmedetomidine effectively controls shivering and takes almost the same time for cessation of shivering as that of tramadol.

- It provides additional benefit of intraoperative sedation without any incidence of nausea and vomiting.

- The recurrence of shivering will more with tramadol.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-02
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 120

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

• 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.
• Any major systemic illness like hypertension, heart block etc.
• Patients with cardio pulmonary , renal and hepatic disease .

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time of onset of shivering (10 minutes intervals) , after given spinal anesthesia	Time of onset of shivering (10minutes intervals) , after given spinal anesthesia | Severity(grading) of shivering | •Time to disappearance of shivering (minute) | •Time of recurrence (min)
Severity of shivering	Time of onset of shivering (10minutes intervals) , after given spinal anesthesia | Severity(grading) of shivering | •Time to disappearance of shivering (minute) | •Time of recurrence (min)
•Time to disappearance of shivering (s)	Time of onset of shivering (10minutes intervals) , after given spinal anesthesia | Severity(grading) of shivering | •Time to disappearance of shivering (minute) | •Time of recurrence (min)
•Time of recurrence (min)	Time of onset of shivering (10minutes intervals) , after given spinal anesthesia | Severity(grading) of shivering | •Time to disappearance of shivering (minute) | •Time of recurrence (min)

Secondary Outcome Measures

Name	Time	Method
Duration of surgery (min)	Duration of spinal anaesthesia (min)

Trial Locations

Locations (1)

Sir T hospital , Bhavnagar; 🇮🇳 Bhavnagar, GUJARAT, India

Sir T hospital , Bhavnagar

🇮🇳Bhavnagar, GUJARAT, India

Dr Jay Kavad

Principal investigator

918460823304

ahirjash146@gmail.com