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A clinical trial to study a drug Dexmedetomedine for maintenance of vitals during surgeries and recovery profile after major surgeries under General anaesthesia.

A prospective, randomized study of Dexmedetomedine infusion for intraoperative hemodynamics and recovery characteristics in major surgeries under General anaesthesia.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030676
Enrollment
80
Registered
2021-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: K319- Disease of stomach and duodenum, unspecified Health Condition 3: C509- Malignant neoplasm of breast of unspecified site Health Condition 4: C189- Malignant neoplasm of colon, unspecified

Interventions

Intervention1: Dexmedetomedine: Loading dose of 1mcg/kg Intravenously Maintenance dose of 0.6mcg/kg intravenously. Intervention2: Endotracheal intubation: Endotracheal tube of appropriate size Of cuff

Sponsors

Aarupadai Veedu medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and II Patient posted for surgeries under GA lasting for more than 2 hours like modified radical mastectomy, radical neck dissection, resection anastomoses, staging laparotomy, etc.

Exclusion criteria

Exclusion criteria: Non consented patients Pregnancy, obese, diabetic, chronic hypertensive, coronary artery disease, AV block Preoperative hypotension/ bradycardia or dysrhythmia Laparoscopic surgeries Anticipated difficult intubation Allergic to the drugs to be used Patient on beta blockers or calcium channel blockers ASA III and above

Design outcomes

Primary

MeasureTime frame
Heart rate Mean arterial pressure Systolic BP Diastolic BPTimepoint: Before loading dose, Before premedication, Immediately after induction, Immediately after intubation, Every 10 mins after intubation till the end of the procedure, Immediately after extubation, Before shifting to PACU, Every 10mins for 1 hour in PACU, Every 15 mins till the first dose of rescue analgesia.

Secondary

MeasureTime frame
Oxygen saturation Postoperative nausea and vomiting Time of recoveryTimepoint: Oxygen saturation for every 10 mins till the first hour in PACU, Post operative nausea and vomiting in the first 2 hours postoperative

Countries

India

Contacts

Public ContactDr S Ranjith kumar

Aarupadai Veedu medical college & hospital, Puducherry.

ranjit9124@gmail.com8056289625

Outcome results

None listed

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