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A CLINICAL TRIAL COMPARING DEXMEDETOMIDINE AND MIDAZOLAM AS INTRAVENOUS SEDATIVE DURING SPINAL ANAESTHESIA.

COMPARISON OF DEXMEDETOMIDINE WITH MIDAZOLAM REGARDING AROUSAL TIME FROM INTRAOPERATIVE SEDATION IN ADULT PATIENTS DURING SPINAL ANAESTHESIA FOR INFRAUMBILICAL SURGERIES.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/02/004376
Enrollment
64
Registered
2014-02-03
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 physical status I and II of either sex, aged between 18-45 years

Interventions

Intervention1: DEXMEDOTOMIDINE: DETAILS:0.5 mcg/kg- loading dose over 10 minutes followed by infusion at a rate of 0.5 mcg/kg/h, intravenously. Control Intervention1: MIDAZOLAM: DETAILS 0.5 mg/kg-loa

Sponsors

North Bengal Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II of either sex, aged between 18-45 years scheduled to undergo elective infraumbilical surgeries under spinal anaesthesia of approximate duration of 2 hours.

Exclusion criteria

Exclusion criteria: a. Patient not willing to accept spinal anaesthesia b. Patient not willing to receive sedation during surgery under spinal anaesthesia c. Patient not willing to participate in the study d. Patient having any of the followingâ?? I. neurological disease II. local infection at the site of inducing the block III. spinal deformity, past history of spine surgery or trauma IV. coagulopathy V. psychiatric illness VI. any history of allergy to the drugs to be used for the study VII. any significant cardiovascular and pulmonary disease VIII. impaired liver or kidney function IX. drug or alcohol use X. pregnancy

Design outcomes

Primary

MeasureTime frame
The time to awakening from sedation (with dexmedetomidine or midazolam) utilizing (i) Bispectral Index Score (BIS)14, (ii) Observer Assessment of Alertness/Sedation (OAAS/S) Score Timepoint: TIME TO ACHIEVE BIS 90 FROM STOPPING INFUSION—

Secondary

MeasureTime frame
1. Time taken for onset of sedation to attain a BIS score 70. 2. OAA/S scores at BIS scores of 70 and 90. 3. Intraoperative haemodynamic parameters (Mean arterial pressure, Heart rate). 4. Intraoperative respiratory parameters (SpO2,Respiratory rate). 5. Patientsâ?? satisfaction regarding quality of intraoperative sedation. 6. Incidences of adverse events if any. Timepoint: every 10 mins until operation is over.—

Countries

India

Contacts

Public ContactSREYYA GANGULY

Department of Anaesthesiology

drmcmandal@gmail.com9474084286

Outcome results

None listed

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