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CONSCIOUS/MODERATE SEDATION CHARACTERISTICS WITH DEXMEDETOMIDINE AND PROPOFOL IN MINOR SURGICAL PROCEDURES - A COMPARATIVE STUDY

â??Is Dexmedetomidine Better Than Propofol in Minor Day care Procedures for moderate sedation characteristics?-A Prospective double blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/11/006357
Enrollment
60
Registered
2015-11-13
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- ASA-I and ASA-II CLASS PATIENTS

Interventions

Intervention1: Group D:: Dexmedetomidine loading dose infusion @ 1 mcg/kg over 10 min
then maintenance infusion initiated at 0.6 mcg/kg/hr and titrated to achieve desired clinical effect with dose ranging from 0.2-0.7mcg/kg. Control Intervention1: Group P:: Propofol at loading dose of
then maintenance @ 1-3mg/kg/hr. Analgesia with fentanyl as 1-2 mcg/kg and anxiolytic midazolam as 0.01-0.05mg/kg bolus is given in every patient.

Sponsors

st stephens hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA class I-II patients. 2. Adults of age group in between 20-50 years. 3. Adults of body weight in range of 40-75 kgs. 4. Surgeries of duration 45 minutes.

Exclusion criteria

Exclusion criteria: Agitated uncooperative patients who refused to provide consent, Patients with history of any of drug allergy, hemodynamically unstable patients like hypotensive patient, cardiac patients with history of angina, conduction defects angioplasty, CABG, severely hypertensive patients, septicemic patients, pregnant women, children below 12 years of age and elderly patients of age above 60 years were excluded from study.

Design outcomes

Primary

MeasureTime frame
Degree of sedation (OAASâ?¤3) was comparable in both groups (p0.05). Rescue analgesia with fentanyl was needed in 30% patients of group D than in 17.63% patients of group P (p0.05). Level of arousal was faster and better in group D at 5min after procedure (p0.05). Hemodynamic were stable in group D as with group P patients (p0.005). Dry mouth reported by 3 patients.Timepoint: Degree of sedation (OAASâ?¤3) was comparable in both groups (p0.05). Rescue analgesia with fentanyl was needed in 30% patients of group D than in 17.63% patients of group P (p0.05). Level of arousal was faster and better in group D at 5min after procedure (p0.05). Hemodynamic were stable in group D as with group P patients (p0.005). Dry mouth reported by 3 patients.

Secondary

MeasureTime frame
Rescue analgesia with fentanyl was needed in 30% patients of group D than in 17.63% patients of group P (p0.05). Dry mouth reported by 3 patients.Timepoint: at the end of procedure.

Countries

India

Contacts

Public ContactGAURAV SINGH TOMAR

st. stephens hospital

cherian.grace@rediffmail.com9716700197

Outcome results

None listed

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