Comparison of ketamine and dexmedetomidine in maintaining the depth of anesthesia
Design
This study will be a double-blind randomized clinical trial on 90 patients referred to Peymaniyeh Hospital in Jahrom who undergo surgery under anesthesia. Patients participating in the study will be divided into three groups by a table of random numbers.
Settings and conduct
Patients referred to Peymaniyeh Hospital in Jahrom who will undergo surgery under general anesthesia in less than an hour will be included in the study. The study participant, researcher, and data collector will be unaware of the type of drug being used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Peymaniyeh Hospital in Jahrom must be candidates for general anesthesia in less than one hour and express their consent to participate in the study. Non-entry conditions: includes patients who do not have hemodynamic stability and have renal disorders.
Intervention groups
Intervention group 1: Simultaneously with anesthesia, a bolus dose of dexmedetomidine and then infusion dose (1μg / kg and 0.5μg / kg / hr) will be administered. Intervention group 2: Simultaneously with anesthesia, a bolus dose of ketamine and then an infusion dose (0.25 mg / kg and 5 μg / kg / min) will be prescribed. Control group: will receive bolus dose and normal saline infusion dose.
Main outcome variables
Depth of anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N5
Registration date:2021-06-22, 1400/04/01
Registration timing:prospective
Last update:2021-06-22, 1400/04/01
Update count:0
Registration date
2021-06-22, 1400/04/01
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-01, 1400/06/10
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ketamine and Dexmedetomidine in Maintenance of Anesthesia with Bispectral Index Scale during General Anesthesia
Public title
Comparison of ketamine and dexmedetomidine in maintenance anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being an NPO for 8 hours
ASA class one or two
Satisfaction with general anesthesia
Exclusion criteria:
High blood pressure
Severe cardiovascular disease
Severe dysfunction of the liver and kidneys
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. With the help of the online site (www.sealedenvelope.com/simple-randomiser/v1/lists) randomization, 8 blocks of 15 are created. In each block, randomly classified, 5 patients are assigned to the ketamine group, 5 patients to the dexmedetomidine group, and 5 patients to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, in the present study, the double-blind method is used so that the person reviewing the results and the person performing the injections do not know which patient received dexmethomedin and ketamine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
Jahrom
Province
Fars
Postal code
7167758256
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.JUMS.REC.1398.045
Health conditions studied
1
Description of health condition studied
General anesthesia
ICD-10 code
A21.7
ICD-10 code description
Generalized tularemia
Primary outcomes
1
Description
Depth of anesthesia
Timepoint
After induction of anesthesia by an observer until the end of anesthesia will continue every 15 minutes.
Method of measurement
Cerebral State Monitor device made by Donmeter.dk company from Denmark and electrocardiographic electrodes will be used.
Secondary outcomes
1
Description
The pain
Timepoint
After surgery in recovery
Method of measurement
Pain is assessed according to the ruler criteria.
2
Description
Frequent nausea and vomiting
Timepoint
In recovery
Method of measurement
Based on the frequency of nausea and vomiting
Intervention groups
1
Description
Intervention group 1: Dexmedetomidine infusion dose of 0.5 to 1 macro / kg body weight per hour will be administered during general anesthesia. The drug dexmedetomidine is used under the brand name Seddox, owned by Themis Medicare, and the vial of NDCC contains 200 micrograms of dexmedetomidine.
Category
Treatment - Drugs
2
Description
Intervention group 2: Ketamine infusion dose of 25. Up to 0.5 macro / kg body weight per hour will be administered during general anesthesia. Ketamine used is made by Pfizer company in Germany and its ampoule contains 10 cc of 500mg solution.
Category
Treatment - Drugs
3
Description
Control group: Simultaneously with anesthesia, a bolus dose of distilled water will be given as a placebo.