Comparison of intravenous administration (giving drug into the vein) of dexmedetomidine (sedative) versus dexamethasone (anti-inflammatory) for prevention of postanaesthetic shivering in patients undergoing laparoscopic cholecystectomy (surgical removal of gallbladder) under general anaesthesia

Efficacy of Prophylactic Intravenous Administration of Dexmedetomidine versus Dexamethasone for prevention of Postanaesthetic Shivering in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030598

Enrollment

100

Registered

2021-01-19

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: O- Medical and Surgical

Interventions

Intervention1: Prevention of postanaesthetic shivering: After the creation of pneumoperitoneum, the study drug will be given in the form of 50ml intravenous drug infusion over 20 min Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either gender giving consent for the study and aged 18-60 years belonging to ASA grade I or II scheduled for elective laparoscopic cholecystectomy under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. Patients with history of myocardial infarction and insufficiency, neuromuscular disorders, hypo- or hyperthyroidism, diabetes or convulsions 2. Pregnant females 3. Patients having pre-operative oral temperature >38â?° or 4. Patients with hemodynamic instability 5. Patients on anti-depressant medication, corticosteroid therapy or allergies to the study drugs 6. Patients with heart blocks or arrhythmia

Design outcomes

Primary

Measure	Time frame
To compare the incidence of PAS after intravenous administration of dexmedetomidine versus dexamethasoneTimepoint: 5 mins after administration of the drug, 10mins, 15mins, 30mins, 1h, 2h, 3h, At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h	—

Secondary

Measure	Time frame
Any other side effects Timepoint: 24h after extubation;Compare the severity of PAS after administration of either of the drugsTimepoint: 5 mins after administration of the drug, 10mins, 15mins, 30mins, 1h, 2h, 3h, At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Hemodynamic parameters at the time of extubationTimepoint: At extubation;Incidence of PONV in each group Timepoint: At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Postoperative hemodynamic parameters in both groupsTimepoint: 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Postoperative pain in both groupsTimepoint: At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Postoperative sedation in both groupsTimepoint: At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Severity grading of PONV in each groupTimepoint: At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h	—

Measure

Time frame

Any other side effects Timepoint: 24h after extubation;Compare the severity of PAS after administration of either of the drugsTimepoint: 5 mins after administration of the drug, 10mins, 15mins, 30mins, 1h, 2h, 3h, At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Hemodynamic parameters at the time of extubationTimepoint: At extubation;Incidence of PONV in each group Timepoint: At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Postoperative hemodynamic parameters in both groupsTimepoint: 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Postoperative pain in both groupsTimepoint: At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Postoperative sedation in both groupsTimepoint: At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h;Severity grading of PONV in each groupTimepoint: At extubation, 15mins after extubation, 30mins, 1h, 2h, 3h, 4h

—

Countries

India

Contacts

Public ContactDr Zulutemjen Tally

UCMS and GTB Hospital

rudoc@rediffmail.com9560678023

Outcome results

None listed

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