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

NACompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

September 5, 2023

Primary Completion Date

October 25, 2023

Study Completion Date

October 26, 2023

Conditions
DoseMidazolamPreoperative
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."

Trial Locations (1)

510655

the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER