Determine the effect of Dexmedetomidine on postoperative shivering after general anesthesia for appendectomy
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
The operation room of Kowsar hospital was similar in all of our patients. The environment and checked for similar light, environmental temperature, drugs and liquids were kept in same rooms with same temperature.
Participants/Inclusion and exclusion criteria
emergent appendectomy patient between15-25 years old. patients with peritonitis, ASA* more 2, past medical history of malignant hyperthermia, seizure, anaphylaxis, cardiovascular disease, dyspnea , diabetes mellitus, renal disease, liver disease, substance use, alcohol use, antiepileptic agent use, psychologic disorders, NSAIDs and usage of any other opioids or drugs for decreasing pain were excluded
Intervention groups
45 Patients was administered dexmedtomedin
Main outcome variables
Shivering
Pain scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120801010471N4
Registration date:2019-01-14, 1397/10/24
Registration timing:retrospective
Last update:2019-01-14, 1397/10/24
Update count:0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Milad Masaeli
Name of organization / entity
Kurdistan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3356 5240
Email address
drmilmas@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2018-05-03, 1397/02/13
Trial completion date
2018-06-22, 1397/04/01
Scientific title
Effect of Dexmedetomidine on postoperative shivering after general anesthesia for appendectomy
Public title
Effect of Dexmedetomidine on postoperative shivering after general anesthesia for appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Emergent appendectomy patients
Exclusion criteria:
Patients with peritonitis
Past medical history of malignant hyperthermia
Seizure
Anaphylaxis
Cardiovascular disease
Diabetes mellitus
Renal disease
Substance use
Liver disease
Alcohol use
Anti epileptic agent use
Psychological disorders
NSAIDs and usage of any other opioids or drugs for decreasing pain
ASA more 2
Age
From 15 years old to 25 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Triple blinded
Blinding description
The personnel that fulfill the questionnaire , nurse,anesthesiologist, data analysand did not know the patients.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pardis of Kurdistan University of Medical scinece, Pasdaran Ave, Azadi Square
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.MUK.REC.1395.385
Health conditions studied
1
Description of health condition studied
Shivering after appendectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Shivering scale
Timepoint
Immediately after general anesthesia, 5, 15, 30, and 60 minutes after general anesthesia
Method of measurement
Shivering was evaluated using a 5-point scale. The scale used was;0 = no shivering; 1 = observation of one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other causes, and/or no visible muscular activity; 2 = visible muscular activity confined to 1 muscle group; 3 = visible muscular activity in more than 1 muscle group; 4 = gross muscular activity involving the entire body.
Secondary outcomes
1
Description
Pain Scale
Timepoint
5,10,15,20
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Fentanyl 2µ/kg as a premedication, Thiopental sodium:5mg/kg and succinylcholin: 1.5mg/kg as induction of anesthesia were administered. Maintenance of anesthesia consists of Isoflurane 1.3 VOL% plus N2O and oxygen in the same concentration (3 L/min). The operation room was similar in all of our patients. The environment and checked for similar light, environmental temperature, drugs and liquids were kept in same rooms with same temperature.Intra venous fluid was infused 7cc/kg Ringer 5-7 minutes before induction of anesthesia. Pre oxygenation by 5-6 liter oxygen by anesthetic mask were done in all patients. Intra venous maintenance was 4cc/kg/h plus 3cc/kg instead of every milliliter of bleeding. Bleeding calculated by gathering the gases in the operation field and the blood in the suction bottle. Temperature was measured base on tympanic membrane temperature in at minutes baseline time,5,15,30,60 after induction of anesthesia.We monitored non invasive blood pressure, puls oximetery, EKG monitoring (lead 2). We administered 1µ/kg dexmedtomedin intravenously 20 minutes before induction of anesthesia during 10 minutes and slowly (1µ/kg diluted in 10cc streel water)in intervention group.
Category
Treatment - Drugs
2
Description
Control group: Fentanyl 2µ/kg as a premedication, thiopental.sodium:5mg/kg and succinylcholin: 1.5mg/kg as induction of anesthesia were administered. Maintenance of anesthesia consists of Isoflurane 1.3 VOL% plus N2O and oxygen in the same concentration (3 L/min).The operation room was similar in all of our patients. The environment, and checked for similar light, environmental temperature, drugs and liquids were kept in same rooms with same temperature.Intra venous fluid was infused 7cc/kg Ringer 5-7 minutes before induction of anesthesia.pre oxygenation by 5-6 liter oxygen by anesthetic mask were done in all patients. Intra venous maintenance was 4cc/kg/h plus 3cc/kg instead of every milliliter of bleeding. Bleeding calculated by gathering the gases in the operation field and the blood in the suction bottle.Temperature was measured base on tympanic membrane temperature in at minutes baseline time,5,15,30,60 after induction of anesthesia.We monitored non invasive blood pressure, puls oximetery, EKG monitoring (lead 2).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar hospital
Full name of responsible person
Milad Masaeli
Street address
Kowsar hospital, Pasdaran Ave, Azadi Square
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3361 1310
Fax
+98 87 3361 1310
Email
drmilmas@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr.Ebrahim Ghaderi
Street address
Pardis of Kurdistan University of Medical scinece, Pasdaran Ave, Azadi Square
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Fax
+98 87 3366 4654
Email
heydari132@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Milad Masaeli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kowsar hospital, Pasdaran Ave, Azadi Square
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3361 1310
Email
drmilmas@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Milad Masaeli
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kowsar hospital,Pasdaran Ave,Azadi Square
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3361 1310
Email
drmilmas@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Milad Masaeli
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kowsar hospital,Pasdaran Ave,Azadi Square
City
سنندج
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3361 1310
Email
drmilmas@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the information in the article will be presented
When the data will become available and for how long
2020
To whom data/document is available
All people related to health
Under which criteria data/document could be used
All people related to health
From where data/document is obtainable
Milad Masaeli
What processes are involved for a request to access data/document