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Role of tapentadol in minimizing severity of patient shivering occurring during surgery

Role of pre-emptive Tapentadol for reducing perioperative shivering of patient undergoing abdominal hysterectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/10/007361
Enrollment
102
Registered
2016-10-13
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 belonging to ASA grade I& II, Age group between 40 and 65 years, Body Mass Index 25 kg/m2±10% posted for abdominal hysterectomy

Interventions

Intervention1: Group A will receive powdered Tab. Tapentadol 75 mg: orally with a sip of water one hour before the scheduled surgery. Control Intervention1: Group B will receive powdered Tab. Tramadol

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to ASA grade I& II, Body Mass Index 25 kg/mt2±10% posted for abdominal hysterectomy lasting less than 120 min

Exclusion criteria

Exclusion criteria: Patients with hypo or hyperthyroidism Axillary temperature above 37°C or below 35â??. Compromised cardio-respiratory functions History of allergy Pregnancy Neuromuscular pathology Cases requiring blood or blood products administration

Design outcomes

Primary

MeasureTime frame
Drug failure (shivering grade 2 or 3)Timepoint: Throughout intraoperative period and first 2 hours of postoperative period

Secondary

MeasureTime frame
Axillary temperatureTimepoint: recorded at 5 min intervals for first 60 min, and thereafter at 15 min intervals for a time duration of 120 min;Haemodynamic parametersTimepoint: recorded at 5 min intervals for first 60 min, and thereafter at 15 min intervals for a time duration of 120 min;occurrence and severity of shiveringTimepoint: Throughout intraoperative period and first 2 hours of postoperative period;SedationTimepoint: recorded at 5 min intervals for first 60 min, and thereafter at 15 min intervals for a time duration of 120 min;Side effectsTimepoint: Throughout the period of observation

Countries

India

Contacts

Public ContactGhanshyam Yadav

Institute of Medical Sciences, Banaras Hindu University

gauravhld@gmail.com8808631209

Outcome results

None listed

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