Effects of low dosage of midazolam plus ketamine and low dose ketamine plus midazolam on shivering

Comparison of the effect of low dosage of midazolam plus ketamine and low dose ketamine plus midazolam on postoperative shivering after spinal anesthesia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160307026950N8

Enrollment

120

Registered

2018-07-27

Start date

2017-06-22

Completion date

Unknown

Last updated

2018-09-11

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

Conditions

shivrring.

Interventions

Intervention 1: Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry,

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: age 18 to 45 years old Candidate for surgery Anesthesia Technique Spinal Anesthesia ASAI,ASAII

Exclusion criteria

Exclusion criteria: Change in Anesthesia Technique Bleeding during blood transfiusion Allergy to the drug

Design outcomes

Primary

Measure	Time frame
Shivering. Timepoint: Recovery Duration. Method of measurement: In minutes using the timer.;Temperature of Peripheral. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Skin Thermometer.;Central temperature. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Tympanic thermometer.;Heart Rate. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Electrocardiogram.;Mean Arterial Blood Pressure. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Non invasive blood pressure measurement.;Oxygen saturation. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Pulse oximetry device.	—

Measure

Time frame

Shivering. Timepoint: Recovery Duration. Method of measurement: In minutes using the timer.;Temperature of Peripheral. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Skin Thermometer.;Central temperature. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Tympanic thermometer.;Heart Rate. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Electrocardiogram.;Mean Arterial Blood Pressure. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Non invasive blood pressure measurement.;Oxygen saturation. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Pulse oximetry device.

—

Secondary

Measure	Time frame
Duration of surgery. Timepoint: The time to start the surgery until the end of the surgery. Method of measurement: Minute.;Duration of stay in recovery. Timepoint: From admission to recovery until discharge. Method of measurement: Minute.;Nausea and Vomiting. Timepoint: During stay in recovery. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Azizollahi

Esfahan University of Medical Sciences

sazizollahi24@gmail.com+98 37764766

Outcome results

None listed

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