The aim of this study was to determine and compare the hemodynamic parameters (systolic and diastolic blood pressure; mean blood pressure; heart rate; O2 saturation) and the patients equilibrium during the steriotaxic surgeries in two groups of receiving zolpidem and placebo.
Design
The clinical trial is randomized, with controlled group, without parallel double blind groups.
Settings and conduct
Participants of elective stereotaxic surgery patients are selected after evaluating entry and exit criteria and are randomly assigned to receive Placebo and Zolpidem . Hemodynamic indices are recorded at the basic time(1hour before surgery), before anesthesia induction, 1, 3, 5,10,15 min after anesthesia, in the time of patient enter and every 15 min to the recovery.
Participants/Inclusion and exclusion criteria
Age between 20 – 65 years old; patients who consent to the informed consent to participate; ASA cslas 1,2; Non- inclusion criteria: use of sedative drugs;addiction to Alcohol; allergic reaction to drug; Parkinsons disease; obstructive sleep apnea; patients who have bradycardia.
Intervention groups
The once group receive 10 mg tablet of zolpidem 1 hour before surgery, The second group receive one tablet of placebo 1 hour before surgery, and Induction of anesthesia with 0.05 mg/kg Midazolam, 2 microgram/Kg Fentanil.
Main outcome variables
Systolic blood pressure; diastolic blood pressure; mean blood pressure; heart rate; saturation of O2.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110528006617N6
Registration date:2021-07-07, 1400/04/16
Registration timing:prospective
Last update:2021-07-07, 1400/04/16
Update count:0
Registration date
2021-07-07, 1400/04/16
Registrant information
Name
Mehrdad Masoudifar
Name of organization / entity
Esfahan University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1268 2007
Email address
masoudifar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survery of the effect of oral zolpidem on hemodinamic signs and the patients Equlibrium in Stereotaxic surgeries.
Public title
The effect of oral zolpidem on hemodinamic indicies and the patients Equlibrium in Stereotaxic surgeries.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 – 65 years old
Patients who consent to the informed consent to participate in the study
ASA class 1,2
Exclusion criteria:
Use of sedative drugs
Addiction to Alcohol
Allergic reaction to drug
Parkinsons disease
Obstructive sleep apnea
Patients who have bradycardia
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Random function "Random Number Generation " of Excel software based on patient file number will be used for randomization. Patients file number were entered into Excel program and patients were divided into case and control groups based on the random button. In total, there were two groups of 64 people. In this case, the file number is entered in Excel program, then a random number is selected from the data analysis command. This study has 2 groups that can be numbered from 1 to 2, respectively. We also want 32 people in each group. As a result, sequences 1 to 2 should be repeated 32 times each time. It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 32 for repeating the sequence. In this way, 64 units will be produced.
Blinding (investigator's opinion)
Double blinded
Blinding description
We produced tablet similar to Zolpidem,The once group received one tablet of Zolpidem 1 hour before surgery and the second group received one tablet of Placebo 1 hour before surgery. So the patients do not have any information about the intervention and the person who registered the information do not know which patient in which group ist and the study has two blind side.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical sciences
Street address
Isfahan University Of Medical Science, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.MUI.MED.REC.1399.655
Health conditions studied
1
Description of health condition studied
General anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Systolic blood pessure
Timepoint
Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery.
Method of measurement
Mm-hg, sphygmomanometer
2
Description
Diastolic blood pressure
Timepoint
Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery.
Method of measurement
Mm-hg, sphygmomanometer
3
Description
Heart rate
Timepoint
Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery
Method of measurement
ECG monitor
4
Description
Mean arterial pressure
Timepoint
Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery
Method of measurement
Mm-hg, sphygmomanometer
5
Description
O2 saturation
Timepoint
Basic time(one hours before surgery), before anesthesia induction, 1,3,5,10,15 min after anesthesia, in the time of patient enter to the recovery and every 15 min time of patient enter to the recovery
Method of measurement
O2 saturation percentage , pulse oximeter device
6
Description
Surgeon Satisfaction
Timepoint
End of the surgery
Method of measurement
Likert Scale
7
Description
Patient Satisfaction
Timepoint
End of the surgery
Method of measurement
Likert Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Initially,personal consent is obtained from the patients.This group receive 10 mg tablet of zolpidem 1 hour before surgery,Then the patient is placed on the perating bed and standard monitoring devices including pulsoximetry,capnography are attached and Induction of anesthesia with 0/05mg/kg Midazolam, 2 microgram/Kg Fentanil .
Category
Treatment - Drugs
2
Description
Control group: Initially,personal consent is obtained from the patients.This group receive tablet of placebo 1 hour before surgery,Then the patient is placed on the perating bed and standard monitoring devices including pulsoximetry,capnography are attached and Induction of anesthesia with 0/05mg/kg Midazolam, 2 microgram/Kg Fentanil .