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Evaluation of the effect of dexmedetomidine on the prevention of postoperative shivering in patients undergoing eye, ear, throat and nose surgeries

Protocol summary

Study aim
Prophylactic effect of dexmedetomidine on postoperative shivering
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 is performed on 100 patients. Patients are randomly divided into two groups (by lottery method).
Settings and conduct
The location of this study is Razi Hospital in Birjand city. The severity of patients' shivering will be evaluated according to the scoring criteria by the intern. Intern and patients will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria will include having informed consent to enter the study, ASA Class 1 and 2. Exclusion criteria: emergency surgery, patients with ASA 3 and above, drug addiction, history of malignant hyperthermia,Seizures, anaphylaxis, Ischemic heart disease, uncontrolled systemic disease, history of using narcotic drugs; Anti-psychosis, analgesia, alcohol, anti-inflammatory drugs, neuromuscular diseases, thyroid, dysautonomia, pregnancy, obesity.
Intervention groups
In both groups, Ringer's serum is injected before induction of anesthesia. Pre-oxygenation with 5 Lit / min oxygen by anesthesia mask and to induce anesthesia in all patients fentanyl 2 kg / µg and thiopental sodium 5 mg / kg and atracurium 0.5 mg / kg will be used. Maintenance of anesthesia in each group will be performed using propofol 50-150 µg / kg / min. In the intervention group, dexmedetomedine (µg / kg 1) was infused intravenously 10 minutes before extubation.(g / kg µ 1 diluted in 50 cc normal saline) In the control group, 50 cc normal saline is infused intravenously 10 minutes before extubation induction and within 10 minutes. Postoperative shivering is measured and recorded at the beginning of recovery and then every 10 minutes to one hour after surgery.
Main outcome variables
Determining the occurrence of shivering in patients in the intervention and control groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211009052704N1
Registration date: 2021-12-04, 1400/09/13
Registration timing: registered_while_recruiting

Last update: 2021-12-04, 1400/09/13
Update count: 0
Registration date
2021-12-04, 1400/09/13
Registrant information
Name
Sara Bakhtiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3894 5167
Email address
bakhtiarisara11@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-09, 1400/07/17
Expected recruitment end date
2022-04-06, 1401/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dexmedetomidine on the prevention of postoperative shivering in patients undergoing eye, ear, throat and nose surgeries
Public title
Evaluation of the effect of dexmedetomidine on the prevention of postoperative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to enter the study ASA Class 1 and 2
Exclusion criteria:
Emergency surgery Patients with ASA 3 and above Drug addiction History of Malignant hyperthermia Seizures Anaphylaxis Severe cardiovascular disease Severe kidney, lung, liver disease or any Uncontrolled systemic disease History of taking anti-psychotic drugs, analgesics, narcotics, alcohol, anti-inflammatory drugs Includes both nsaid and corticosteroids Neuromuscular diseases Thyroid disease, Dysautonomy, Obesity (BMI> 30), Pregnancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided into two groups. Each patient will enter one of the intervention groups randomly before going to the operating room using the color cards that are placed in the envelope and the patient will choose one. For example, if a yellow card is selected, the patient will be in the group receiving dexmedetomidine and if a blue card is selected, the patient will be in the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The severity of shivering in patients is classified by the intern without knowing the patient group. Patients and the evaluator do not know their group and the drug received (double-blind study).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari blvd,Birjand town
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2021-10-09, 1400/07/17
Ethics committee reference number
IR.BUMS.REC.1400.201

Health conditions studied

1

Description of health condition studied
The effect of dexmedetomidine on the prevention of postoperative shivering in patients undergoing eye, ear, throat and nose surgeries
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Classification of shivering
Timepoint
Classification of shivering immediately after recovery, 10, 20, 30, 40, 50, 60 minutes after surgery
Method of measurement
Zero = lack of muscle tremor / 1 = hair straightening, peripheral cyanosis / 2 = muscle tremor visible in one muscle group / 3 = muscle tremor visible in more than one muscle group / 4 = muscle tremor visible in all muscles of the body by The ward intern will be evaluated without informing the patient group.

Secondary outcomes

1

Description
Comparison of mean systolic and diastolic blood pressure
Timepoint
Comparison of mean systolic and diastolic blood pressure immediately after recovery, 10, 20, 30, 40, 50, 60 minutes after surgery
Method of measurement
Patients' blood pressure is measured with a sphygmomanometer cuff at regular intervals and recorded in prepared tables.

2

Description
Comparison of mean pulse beats
Timepoint
Comparison of mean pulse beats immediately after recovery, 10, 20, 30, 40, 50, 60 minutes after surgery
Method of measurement
Patients' pulse is counted in one minute.

Intervention groups

1

Description
Intervention group: The group of patients is injected with Ringer serum according to the relevant formulas before induction of anesthesia. Pre-oxygenation with 5 Lit / min oxygen is performed by anesthesia mask for all patients. Fentanyl(Darou Pakhsh Pharmaceutical Co./and each vial is 50 micrograms per 10 cc) 2 kg / µg, thiopental sodium(Panpharma Co./500mg) 5 mg / kg and atracurium(Aburaihan ‌Pharmaceutical Co/50 mg per 5 ml) 0.5 mg / kg will be used to induce anesthesia in all patients. Maintenance of anesthesia in each group will be performed using propofol(Fresenius Kabi Co./200 mg per 20 ml) 50-150 µg / kg / min. Temperature All serums were the same and all were supplied from the shared serum storage room. Room temperature between 25-28 degrees and a serum was randomly selected daily to measure the temperature. Environment: Light and temperature were equal and the drugs and liquids were kept in the same rooms in terms of temperature.Monitoring: Routine including ECG, pulse oximetry, NIBP every 10 minutes and capnography were performed for all patients. In the intervention group, dexmedetomedin (1 µg / kg 1) was infused intravenously 10 minutes before extubation. (1 µg / kg diluted in 50 cc normal saline).The vials are provided by Exir Company, Boroujerd, Iran. Each vial is 200 micrograms in 2 ml
Category
Prevention

2

Description
Control group: patients is injected with Ringer serum according to the relevant formulas before induction of anesthesia. Pre-oxygenation with 5 Lit / min oxygen is performed by anesthesia mask for all patients. Fentanyl 2 kg / µg, thiopental sodium 5 mg / kg and atracurium 0.5 mg / kg will be used to induce anesthesia in all patients. Maintenance of anesthesia in each group will be performed using propofol 50-150 µg / kg / min.Temperature All serums were the same and all were supplied from the shared serum storage room. Room temperature between 25-28 degrees and a serum was randomly selected daily to measure the temperature. Environment: Light and temperature were equal and the drugs and liquids were kept in the same rooms in terms of temperature.Monitoring: Routine including ECG, pulse oximetry, NIBP every 10 minutes and capnography were performed for all patients. In the control group, 50 cc of normal saline is infused intravenously 10 minutes before induction of extubation and within 10 minutes. Fentanyl provided by Darou Pakhsh Pharmaceutical Co. and each vial is 50 micrograms per 10 cc. thiopental sodium provided by Panpharma Co./500mg. atracurium provided by Aburaihan ‌Pharmaceutical Co. / 50 mg per 5 ml and propofol provided by Fresenius Kabi Co. 200 mg per 20 ml.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Bibifateme Shakhsimampoor
Street address
Ghafari Blvd, Birjand,South Khorasan Province
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
public_r@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghafari blvd,Birjand,South Khorasan
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
public_r@bums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Bibifateme Shakhs Imampoor
Position
Specialist and Assitanat professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghafari blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
shakhsemampour@bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Bibifateme Shakhs Imampoor
Position
Specialist and assitant proffessor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghafari blvd. Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
shakhsemampour@bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Sara Bakhtiari
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 38,Ghafari 14,Ghafari blvd
City
Birjand
Province
South Khorasan
Postal code
9716643135
Phone
+98 51 3894 5167
Email
bakhtiarisara11@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
Data related to hemodynamic parameters of the subjects included shivering intensity, heart rate. Patients' systolic and diastolic blood pressure are measured at regular intervals will be released after the person is unidentified and the effect of the interventions is described in a general article.
When the data will become available and for how long
Accessibility after publishing the article
To whom data/document is available
Published data is accessible to all people working in different fields.
Under which criteria data/document could be used
The data can be used for review and use to develop guidelines and further research on this drug.
From where data/document is obtainable
After completing the study, the documents will be registered in the Pazhoohan.
What processes are involved for a request to access data/document
The application will be shared within two working weeks if eligible after review by the project manager.
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