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ED50 of Midazolam Oral Solution for Preoperative Hypnosis in Adults : An Up-and-Down Sequential Allocation Trial

NCT06018207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-08-06

No results posted yet for this study

Summary

Due to sleep deficiency, patients with insomnia syndrome or sub-clinical insomnia syndrome often undergo severe stress while waiting for surgery. Studies have reported that preoperative hypnosis could reduce stress and promote recovery. Midazolam has been recommended to patients who under severe stress for preoperative sedation and anti-anxiety. However, midazolam for preoperative hypnosis monitored with polysomnography (PSG) has not been studied. In this exploratory study, the median effective dose (ED50) and ED95 of Midazolam Oral Solution for preoperative hypnosis in non-elderly adults using the gold standard tool of PSG, will be explored by up-and-down sequential allocation and probit method.

Conditions

  • Dose
  • Midazolam
  • Preoperative

Interventions

DRUG

Midazolam oral solution

The ED50 dose of midazolam oral solution for hypnosis is studied using an up-and-down sequential allocation while waiting for surgery and general anesthesia in preoperative room. The starting dose is 6 mg and the step size is 1 mg. The interval sequential dose is varied by 1 mg based on the hypnosis response of the previous patient after one hour. Definition of successful hypnosis by taking midazolam oral solution: The polysomnograph (PSG) not only shows stage N2 within 30 minutes, but also shows stage N3 within an hour; or else, definition of unsuccessful hypnosis. The procedure is as follows: (1) The first subject is given 6mg of midazolam oral solution; (2) If succeed, the second subject takes 5mg; (3) If not succeed, the second subject takes 7mg; (4) Until seven sequence reversal inflection points.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jin sanqing, MD · The Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2023-10-25
Completion
2023-10-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06018207 on ClinicalTrials.gov