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Assessment The effect of hypothermia prevention program on shivering, core body temperature and recovery time in patients undergoing abdominal surgery

Protocol summary

Study aim
The effect of hypothermia prevention program on shivering, recovery time, central body temperature in patients undergoing abdominal surgery in teaching hospitals of Zahedan University of Medical Sciences in 2019_2020
Design
This study will be performed on 80 patients (male / female) undergoing abdominal surgery who are admitted to n teaching hospitals in2019-2020. They were randomly divided into control and intervention groups.
Settings and conduct
Zahedan University of Medical Sciences Hospitals، In this study, 80undergoing abdominal surgery will be randomly assigned to 40 patients in the control room of routine operating room care. And 40 patients in the intervention group will be heated and disinfected with a heated disinfectant at 32 ° C. Serum infusion will be performed at 37 to 40 ° C. And transferred to the bed after surgery. The patient's central temperature, chills, and hemodynamic characteristics will be measured at seven specified times.And the time spent in recovery is also recorded
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients undergoing elective abdominal surgery, patients receiving general anesthesia, ASA class 1 and 2 patients, surgical incisions above 5 cm, surgery time of at least one hour. Exclusion criteria:Occurrence of any condition affecting the patient's normal anesthesia and surgery, underlying diseases, intraoperative blood transfusion, intravenous fluids greater than 5 liters, significant hypotension during surgery, and non-steroidal analgesic and magnesium sulfate administration
Intervention groups
Group1:Patients according to routine, prep, drep and fluid infusion the same room temperature will receive. Group 2: Patients Under intervention, receive a hypothermia prevention program during and after surgery.
Main outcome variables
Central body temperature, chills, recovery time, hemodynamic status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200304046691N1
Registration date: 2020-04-09, 1399/01/21
Registration timing: registered_while_recruiting

Last update: 2020-04-09, 1399/01/21
Update count: 0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Tayebeh Azarmehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3269 4179
Email address
t.azarmehr74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-26, 1398/12/07
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment The effect of hypothermia prevention program on shivering, core body temperature and recovery time in patients undergoing abdominal surgery
Public title
The effect of care plan on body temperature and recovery time
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing elective abdominal surgery including abdominal hernia and open hysterectomy and open cystectomy Patients receiving general anesthesia ASA class 1 and 2 patients Surgical incisions above 5 cm Surgery time of at least one hour and maximum of 2.5 hours
Exclusion criteria:
Occurrence of any condition affecting the patient's normal anesthesia and surgery, such as excessive bleeding and cardiac arrest during surgery Having underlying diseases (thyroid, diabetes, cardiovascular disease and chronic hypertension) Receiving blood and blood products during surgery Intravenous fluids greater than 5 liters during surgery, temperatures above 37.5 ° C or less than 36.5 ° C before surgery Significant hypotension during surgery (20% blood pressure lower than before anesthesia) Endocrine Disorders Corticosteroid intake Non-steroidal analgesic and magnesium sulfate Fever, and addiction Prohibition on controlling body temperature through the tympanic membrane Lack of patient satisfaction
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Permutation block randomization will be used to allocate participants randomly،So that 80 envelopes are made and each envelope is labeled as A or B. When the first patient meets the inclusion criteria, the first envelope is opened and given the name of the group, if A was in the intervention group and if B was in the control group, the same would be done until the last sample. Comments will be made.
Blinding (investigator's opinion)
Single blinded
Blinding description
The sampling conditions are randomized so that the patient is not aware of the measures to be taken, but since the parameters are measured by the researcher, the blinding researcher does not. The permutation block randomization method will be used
Placebo
Not used
Assignment
Parallel
Other design features
In our study, hypothermia prevention protocol is performed on patients with general anesthesia for abdominal surgery.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research and technology of Mazandaran University of Medical Sciences
Street address
Sari, Imam Square, Jouybar Road, Valiasr Highway, Central Headquarters of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2020-02-26, 1398/12/07
Ethics committee reference number
IR.MAZUMS.REC.1398.1391

Health conditions studied

1

Description of health condition studied
Patients undergoing abdominal surgery Like cholecystectomy
ICD-10 code
K91.86
ICD-10 code description
Retained cholelithiasis following cholecystectomy

2

Description of health condition studied
Patients undergoing abdominal surgery Like abdominal hernias
ICD-10 code
K43.2
ICD-10 code description
Incisional hernia without obstruction or gangrene

3

Description of health condition studied
Patients undergoing abdominal surgery Like a hysterectomy
ICD-10 code
N99.3
ICD-10 code description
Prolapse of vaginal vault after hysterectomy

Primary outcomes

1

Description
Central body temperature
Timepoint
Before Intervention - During Intervention - After Intervention
Method of measurement
Based on the temperature and using a tympan thermometer

2

Description
shiver
Timepoint
During the intervention - after the intervention
Method of measurement
Will be reviewed according to the Crossley classification. Grade 1 = no shiver, grade 2 = slight shivering (straightening of hair, peripheral cyanosis without visible shake), grade 3 = moderate shivering (visible muscle shake in a group of muscles), grade 4 = severe shivering (muscle shake in All body muscles)

3

Description
Recovery time
Timepoint
after surgery
Method of measurement
timer

Secondary outcomes

1

Description
blood pressure
Timepoint
Before intervention - During intervention - After intervention
Method of measurement
Systolic and diastolic blood pressure monitored using a millimeter of mercury

2

Description
Number of pulses
Timepoint
Before intervention - During intervention - After intervention
Method of measurement
Using the monitor on a per-minute basis

3

Description
Breath rate
Timepoint
Before intervention - During intervention - After intervention
Method of measurement
Using the monitor on a per-minute basis

4

Description
Percentage of arterial blood oxygen saturation
Timepoint
Before intervention - During intervention - After intervention
Method of measurement
Using a monitor based on percentages

Intervention groups

1

Description
Intervention group: This clinical trial study will be performed on 80 candidates undergoing abdominal surgery by general anesthesia referring to the operating room of teaching hospitals of Zahedan University of Medical Sciences. Given the random allocation, 40 patients in the intervention group, in this group, after being admitted to the operating room on the surgical bed, received anesthesia induction drugs according to the standard protocol (receiving anesthesia would be the same in both groups) and then receiving permission from the team،intervention Under the heading of a hypothermia prevention program, it is performed on patients with entry criteria, which، Anesthetist will scrub and drip using a heated disinfectant up to 32 ° C (by Warmer machine). Infusion of injectable liquids will begin with warm serum of 37 degrees. After surgery, patients are transferred to the recovery bed. This bed and blanket were prepared half an hour before the patient was transferred to recovery by two to three 40-by-60-cm warm water bags pre-heated with standard anesthetic (Fig. 1) so after placement The patient will be warm on the bed Both the bed and the blanket on the patient will be followed by two smaller warm water bags in the axillary and thigh area of ​​the patient.In both groups, data will be collected on the basis of data collection forms, including personal information and information on surgery and anesthesia, as well as recording of central temperature, blood pressure, pulse and arterial oxygen saturation, chills. And it will be a recovery time. Seven times will be measured: 5 minutes before anesthesia, 5 minutes after induction of anesthesia, 30 minutes after surgery, after surgery,On arrival to recovery, 0.5 hours and 1 hour after transfer. The patient will be monitored for recovery
Category
Prevention

2

Description
Control group: 40 patients in the control group received routine, routine operating room care, including perforation, drip, and infusion of operating room temperature fluid, and will be transferred to recovery beds after surgery. They will be covered with routine blankets.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Operating Room of Zahedan University of Medical Sciences Teaching Hospitals
Full name of responsible person
Zahra Pishkar Mofrad
Street address
Zahedan, Persian Gulf Boulevard - Imam Ali Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
t.azarmehr74@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Agricultural Boulevard, Amir Mazandarani Street،Plaque140
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4850
Fax
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Tayebeh Azarmehr
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghadir Shahr, 18 Meters From Al-Zahra, The Intersection of The Martyr Lekzai and The Flower of Maryam
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9818921847
Phone
+98 54 3269 4179
Email
t.azarmehr74@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Houshang Akbari
Position
Assistant Professor, Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sari, Jouybar Three-way, At the beginning of Valiasr Highway, Headquarters of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
Hooshangakbari48@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tayebeh Azarmehr
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Operating Room Surgery Technology
Street address
Ghadir Shahr, 18 Meters From Al-Zahra, The Intersection Of The Martyr Lekzai and The Flower of Maryam
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9818921847
Phone
+98 54 3269 4179
Email
t.azarmehr74@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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