Comparison of the effect of irrigation fluid at room temperature with irrigation fluid to body temperature on hypothermia and other intraoperative and postoperative outcomes in patients undergoing transurethral resection of prostate (TURP) under spinal anesthesia
Determination of the effect of irrigation fluid temperature on hypothermia and other intraoperative and postoperative outcomes in patients undergoing transurethral resection of prostate (TURP) under spinal anesthesia
Design
Phase 3 clinical trial with control group, with parallel groups, double-blind, randomized by block randomization method with blocks of size 4 with a ratio of 1 to 1 (as two groups A and B), with a sample size of 76 patients
Settings and conduct
The study will be performed in the urology operating room of Razi Hospital in Rasht.
The study will be double blind in which neither the patient nor the researcher responsible for completing the questionnaires is aware of the type of serum allocated to surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having ASA class I, II; age between 40 to 75 years; body mass index between 18 to 30; duration of operation less than 2 hours.
Exclusion criteria: patients with active infection; taking antipyretic drugs within 24 hours before surgery; neuropathy; thyroid dysfunction; peripheral vascular disease, severe skin lesions or allergies; contraindications spinal anesthesia; history of ACEI or CCB
Intervention groups
Intervention group 1: Using irrigation fluid warmed to body temperature (37 degrees).
Control group: Using irrigation fluid at room temperature.
Main outcome variables
Hypothermia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011766N6
Registration date:2021-01-09, 1399/10/20
Registration timing:registered_while_recruiting
Last update:2021-01-09, 1399/10/20
Update count:0
Registration date
2021-01-09, 1399/10/20
Registrant information
Name
Hossein Khoshrang
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 0028
Email address
khoshrang@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-12, 1399/09/22
Expected recruitment end date
2021-10-14, 1400/07/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of irrigation fluid at room temperature with irrigation fluid to body temperature on hypothermia and other intraoperative and postoperative outcomes in patients undergoing transurethral resection of prostate (TURP) under spinal anesthesia
Public title
Effect of irrigation fluid temperature on hypothermia and other outcomes of anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients candidate for elective transurethral prostatectomy under spinal anesthesia
The ASA Physical Status Classification I,II (normal healthy patient or patient with mild systemic disease)
Age between 40 to 75 years
Body mass index (BMI) more than 18 and less than 30 kg/m2
Operating time less than 2 hours
Exclusion criteria:
Active infection
taking antipyretic drugs within 24 hours before surgery
neuropathy
thyroid dysfunction or thyroid hormone use
peripheral vascular disease
skin lesions or history of severe skin contact allergies
contraindications to spinal anesthesia
history of ACEI or CCB use due to impaired self-regulatory mechanism of the patient's body temperature
history of bleeding disorders
history of taking anticoagulants
Age
From 40 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of size 4 with a ratio of 1 to 1 (as two groups A and B) via a online program named sealed envelop/randomisation
Blinding (investigator's opinion)
Double blinded
Blinding description
One of the researchers (anesthesia resident) will allocate serums to patients in two groups A (serum at room temperature) and B (serum heated to body temperature 37 degrees) based on a table prepared from random blocks. Neither the patient nor the evaluator is aware of the type of serum assigned to the surgery. At the top of the checklist which be completed for each patient, the group type (A or B) will be recorded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Razi Hospital, Sardar Jangal street
City
Rasht
Province
Guilan
Postal code
41448-95655
Approval date
2020-10-07, 1399/07/16
Ethics committee reference number
IR.GUMS.REC.1399.322
Health conditions studied
1
Description of health condition studied
Hypothermia
ICD-10 code
T88.51
ICD-10 code description
Hypothermia following anesthesia
Primary outcomes
1
Description
Hypothermia
Timepoint
Upon arrival of the patient in the operating room, at the beginning of the operation, 30 minutes after the start of the operation, at the end of the operation, in the recovery
Method of measurement
The tympanic method means placing a thermometer in the patient's ear and monitoring the temperature during surgery
Secondary outcomes
1
Description
Heart rate
Timepoint
Heart rate are recorded every 5 minutes during surgery.
Method of measurement
Register in the checklist
2
Description
Blood pressure
Timepoint
Blood pressure are recorded every 5 minutes during surgery
Method of measurement
Register in the checklist
3
Description
Hemoglobin
Timepoint
Hemoglobin is checked before and after surgery through a blood test.
Method of measurement
Register in the checklist
4
Description
The amount of transfusion
Timepoint
The amount of transfusion will also be recorded in the operating room.
Method of measurement
Register in the checklist
5
Description
Recovery time
Timepoint
The recovery time is recorded in the patient file in the operating room.
Method of measurement
Register in the checklist
6
Description
Hospital stay
Timepoint
The hospital stay is calculated on the day of discharge.
Method of measurement
Register in the checklist
Intervention groups
1
Description
Intervention group: Irrigation fluid (normal saline 0.9%) warmed to body temperature (37 degrees) using boiler device (made in Iran, sazgar steam (sazgarmed), with a capacity of 9 serums 35 * 30 * 30) to the required number, which varies for each patient depending on individual characteristics and operation time
Category
Treatment - Devices
2
Description
Control group: Irrigation fluid (normal saline 0.9%) with room temperature (between 21 and 23 degrees)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Hossein Khoshang
Street address
Sardar-e-Jangal street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
khoshrang@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Siavash Falahatkar
Street address
Sardar-e-Jangal Avenue
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc@gums.ac.ir
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Center, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Foroughifar
Position
Anesthesia resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Razi Hospital, Sardar Jangal St.
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
dr_forooghifar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hossein Khoshrang
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sardar-e-Jangal Ave.
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
hkhoshrang@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Non-faculty researcher
Latest degree
Master
Other areas of specialty/work
Urology
Street address
Razi Hospital, Sardar Jangal St.
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
samaneh_815@yahoo.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