Determination of the most effective drug among ketamine, dexmedetomidine and granisetron to prevent shivering after general anesthesia
Design
Triple-blind randomized clinical trial, with control group and parallel group design, with 4 groups
Settings and conduct
In this triple_blind study, 148 patients candidates for laparoscopic cholecystectomy surgery under general anesthesia that referred to Arak's Valiasr Hospital will randomly be allocated into 4 equal groups. Each group receives one of these drugs: Dexmedetomidine, Granisetron, Ketamine, and placebo (normal saline). Patients, Clinical Caregiver and analyzer will be kept blind in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 18 to 65 years; ASA class 1 or 2; being candidate for abdominal laparoscopic surgery under general anesthesia; satisfaction with the study participation.
Exclusion criteria: cardiovascular disease, kidney or endocrine disease, smoking and drugs, pregnancy
Intervention groups
Intervention group 1: Dexmedetomidine, Intervention group 2: Ketamine, Intervention group 3: Granisetron, control group: normal saline (placebo).
Main outcome variables
Post Anesthetic shivering; Body temperator
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191101045300N1
Registration date:2019-12-28, 1398/10/07
Registration timing:registered_while_recruiting
Last update:2019-12-28, 1398/10/07
Update count:0
Registration date
2019-12-28, 1398/10/07
Registrant information
Name
Yazdan Shabani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
yazdansh74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-21, 1398/05/30
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Dexmedetomidine, Granisetron and Ketamine on preventing post operative shivering after general anesthesia
Public title
Comparison effect of Dexmedetomidine and Granisetron and ketamine to preventing post-operative complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18 to 65 years old
ASA class 1 or 2
Patients candidate for abdominal laparoscopic surgery
Satisfaction with study participation
BMI<35
Exclusion criteria:
Being allergic to the prescribed medicines
cardiovascular disease, kidney or endocrine disease
smoking and addiction
chronic Pulmonary Diseases (Asthma and COPD)
pregnancy
history of previous laparoscopy or previous laparotomy
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Random block allocation by statistical software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is triple-blind.The person responsible for recording patient's clinical signs in the recovery room , and the patients and the one who finally analyzes the results, all of them are not aware of used drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences