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Sedation during spinal anaesthesia

Comparison of propofol with midazolam regarding arousal time from sedation during spinal anaesthesia in adult patients undergoing elective infraumbilical surgeries.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/08/002934
Enrollment
110
Registered
2012-08-30
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- Either sex, age between 18 to 60 years, ASA I and ASA II, posted for elective infraumbilical surgical, gynaecological, or orthopaedic operations.

Interventions

Intervention1: Propofol: Intravenous bolus 1 mg/kg follwed by infusion 3 mg/kg/hr of propofol for sedation during spinal anaesthesia titrated to maintain BIS 65-70 Control Intervention1: Midazolam: in

Sponsors

NORTH BENGAL MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex, of age between 18 to 60 years complying to ASA I and ASA II criteria, who are posted for elective infraumbilical operations (be it surgical, gynaecological, or orthopaedic), of approximate 90 mins duration.

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?? Neurological Disease Local infection at the site of inducing the block Spinal deformity, past history of spine surgery or trauma Coagulopathy Psychiatric Illness Any history of allergy to the drugs to be used for the study Any significant cardiovascular and pulmonary disease.

Design outcomes

Primary

MeasureTime frame
arousal time from sedation following stoppage of infusionTimepoint: arousal time from sedation following stoppage of infusion

Secondary

MeasureTime frame
1.time of onset of sedation 2.intraoperative haemodynamic changes 3.patientsâ?? satisfaction regarding quality of intraoperative sedation 4.adverse events if any. Timepoint: 1.time to onset of sedation:from start of infusion of study drug to the desired level of sedation 2.intraoperative haemodynamic changes: with respect to changes in Mean Arterial Pressure (MAP)in mm of Hg and the changes in heart rate (bpm)at 10 min interval 3.patients satisfaction: at the point of recovery 4.adverse events: intraoperative

Countries

India

Contacts

Public ContactDIPANJAN BAGCHI

Department of Anaesthesiology, North Bengal Medical College

drmcmandal@gmail.com9433072820

Outcome results

None listed

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