A randomised double blinded study comparing sublingual Zolpidem spray and Intravenous Midazolam for intraoperative sedation during spinal anaesthesia

EFFICACY OF SUBLINGUAL ZOLPIDEM SPRAY VS INTRAVENOUS MIDAZOLAM FOR INTRAOPERATIVE SEDATION DURING SPINAL ANAESTHESIA: A RANDOMISED CLINICAL STUDY - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098606

Enrollment

140

Registered

2025-12-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Sublingual Zolpidem spray: 2 Sublingual sprays of Zolpidem a total of 10 mg with 1 ml of normal saline IV 10 minutes before spinal anesthesia Control Intervention1: IV Midazolam: 2 spra

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade 1 and 2 patients posted for surgeries with spinal anaesthesia

Exclusion criteria

Exclusion criteria: History of psychiatric disorders or chronic benzodiazepine/hypnotic use ,Pregnant or lactating women ,Patients with H/O any drug allergies ,Patient refusal ,Any adjuvants added to spinal drug during spinal anaesthesia ,Obese and OSA patient ,Difficult airway

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of sublingual Zolpidem spray VS Intravenous Midazolam in providing intraoperative sedation during spinal anaesthesia.Timepoint: At 0,5,20,60,120 minutes	—

Secondary

Measure	Time frame
To measure & compare response to spinal needle insertion by spinal needle insertion score Timepoint: During spinal needle insertion;To measure & compare the overall recovery profile by Aldrete score Timepoint: At recovery room;To measure & compare the patient satisfaction by Likert scoreTimepoint: At recovery room	—

Countries

India

Contacts

Public ContactSoorej Jaiboi K

Mahatma Gandhi Medical College and Research Institute

Arthipre29@gmail.com9447524028

Outcome results

None listed

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