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A clinical trial to study the effects of two sedative drugs, propofol and dexmedetomidine on diaphragm, in patients undergoing surgery under regional anaesthesia.

COMPARISON OF DIAPHRAGMATIC ACTIVITY BETWEEN PROPOFOL AND DEXMEDETOMIDINE SEDATION IN SPONTANEOUSLY BREATHING PATIENTS UNDER REGIONAL ANAESTHESIA : PROSPECTIVE, RANDOMIZED, COMPARATIVE STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035454
Enrollment
126
Registered
2021-08-05
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: B- Imaging

Interventions

Intervention1: PROPOFOL: a bolus of 0.5 mg/kg will be given over 10 minutes followed by 1-2 mg/kg/hr infusion Control Intervention1: DEXMEDETOMIDINE: a bolus of 1 mcg/kg will be given over 10 minutes

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA I or II patients 2. Age group of 18â??60 years 3. Scheduled for elective surgery 4. Requiring regional anesthesia, that doesnâ??t affect their diaphragmatic function

Exclusion criteria

Exclusion criteria: 1. Patientâ??s refusal 2. Contraindication to regional anesthesia 3. History of hypersensitivity to propofol, dexmedetomidine, or local anesthetics 4. Neurologic or muscular disease 5. Patients on anticholinergic drugs 6. Patient receiving Premedications

Design outcomes

Primary

MeasureTime frame
To compare the Diaphragmatic Thickness Fraction (DTF) between patients under propofol and dexmedetomidine sedation during elective surgery under regional anesthesia.Timepoint: Throughout the intraoperative period and immediate post operative period.—

Secondary

MeasureTime frame
To compare between the two groups the following parameters: 1. Diaphragmatic excursion 2. Diaphragmatic velocity 3. Time to return of diaphragmatic function after stopping sedationTimepoint: Throughout the intraoperative period and immediate post operative period.—

Countries

India

Contacts

Public ContactParthasarathy Lankapalli

All India Institute of Medical Sciences

bikashray.aiims@gmail.com9899323110

Outcome results

None listed

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