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A clinical trial to study the effects of two drugs,amino acid and tramadol in preventing post operative shivering in major abdominal surgery patients under general anesthesia

Comparative study to assess the prevention of post operative shivering using preoperative infusion of aminoacid vs tramadol in major abdominal laparotomies under general anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051835
Enrollment
100
Registered
2023-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: N00-N99- Diseases of the genitourinary system Health Condition 3: 4- Measurement and Monitoring Health Condition 4: O- Medical and Surgical Health Condition 5: C00-D49- Neoplasms Health Condition 6: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Preoperative infusion of drugs either amino acid or tramadol: Given over one hour intravenously prior to induction of anaesthesia Control Intervention1: Preoperative infusion of amino a

Sponsors

ESIC MEDICAL COLLEGE AND HOSPITAL, K.K.NAGAR, CHENNAI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Normothermic patients posted for elective major abdominal laparotomy surgery 18 â?? 60 years of age ASA physical status I,II, III

Exclusion criteria

Exclusion criteria: Known allergy to amino acids and tramadol Patient refusal Patients with acute febrile illness or raised total WBC count of more than 11000 cells/cu mm Pregnant and lactating women Respiratory diseases such as chronic obstructive pulmonary disease , bronchial asthma Severe kidney disease, liver disease , seizure disorder and cardiovascular disease ASA IV and above

Design outcomes

Primary

MeasureTime frame
Crossley and Mahajan five-point scale for shiveringTimepoint: 1 hour before anaesthesia to 2 hours after surgery—

Secondary

MeasureTime frame
Incidence of shiveringTimepoint: During surgery and 2 hours post operatively—

Countries

India

Contacts

Public ContactDR SAVITHA V

ESIC MEDICAL COLLEGE AND HOSPITAL,K.K.NAGAR, CHENNAI

savitha.vels@gmail.com8668107031

Outcome results

None listed

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