Protocol summary

Study aim
Comparison of the effect of warm CO2 gas blowing with local heat and the control group on hemodynamic changes, temperature, shivering and shoulder pain after surgery in patients who are candidates for laparoscopic cholecystectomy surgery in Shohada Mehrab H, Yazd in 1403
Design
The clinical trial with a control group, a blind, randomized, on 93 patients, was used for randomization
Settings and conduct
According to the number on the envelope, the researcher determines the type of intervention and takes action. Before the surgery (demographic information, temperature and hemodynamic parameters of the patient) will be recorded in all groups. group A: warm carbon dioxide gas to cause pneumoperitoneum in patients. group B: use from CO2 gas at room temperature and two warm water bags on the common site of pain (in the shoulder area) group C: used CO2 gas is at room temperature. During surgery, the patient's temperature and hemodynamic parameters, the surgeon's satisfaction level in terms of surgical field bleeding will be recorded. After the end of shivering surgery, hemodynamic parameters, temperature, pain are recorded. Sampling location of Shahada Mehrab Hospital, Yazd; The study is a blind study and patients receive the type of intervention on the envelope after anesthesia, and the patient does not know the type of intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range from 18 to 60 years; ASA Ⅰ & Ⅱ; BMI (5/18-9/24) ; Informed consent Exclusion criteria: Converting laparoscopic surgery to an open surgery; adhesions; the duration of the surgery is more than one hour; the history of alcohol and smoking
Intervention groups
A: using Warm carbon dioxide gas, B: using local heat in the common place of shoulder pain. C: use of carbon dioxide gas at normal temperature
Main outcome variables
shoulder pain; Temperatures; hemodynamic parameters; Shivering

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240503061632N1
Registration date: 2024-06-22, 1403/04/02
Registration timing: registered_while_recruiting

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Saeedeh Vaziri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3526 4582
Email address
saeedeh.vaziri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2024-07-31, 1403/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Warm CO2 Insufflation and Local Heat on Hemodynamic Changes, Temperature, Chills, and Shoulder Pain After Surgery in Patients Undergoing Laparoscopic Cholecystectomy
Public title
Investigating the effect of crane gas, hot dioxide and local heat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 60 years American Society of Anesthesiology class 1 and 2 BMI (5/18- 9/24) Informed consent to participate in the study
Exclusion criteria:
In cases where laparoscopic surgery becomes an open surgery, Adhesions detected by the surgeon If the duration of surgery is more than one hour History of alcohol consumption Smoking history
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the study, eligible patients are assigned to three groups using block randomization. Then, six blocks are set with three letters (A: hot gas intervention group, B: local heat intervention group, and C: control group). With 27 possible blocks (from number 1 to 27), 15 blocks of six in each group are selected randomly until the sample size is completed, and by determining the Master sheet and matte envelopes, the list of continuous admission of patients from number 1 to 93 is on the envelope. And the type of intervention is specified inside the envelope. The main list remains with the senior researcher. The researcher was present in the operating room on the day of the operation and after examining the patients, if the patients are eligible, the envelope is opened according to the number on the envelope that is in the possession of one of the operators, and the type of intervention is specified and action taken
Blinding (investigator's opinion)
Single blinded
Blinding description
one blinded - Patients - After obtaining a written consent from the patient, The patient will be anesthetized, and then the Intended intervention will be applied (at the same time as the surgery, a warm water bag is placed in the common place of shoulder pain, or warm CO2 gas is injected into the abdomen after the surgical incision, or no intervention is performed). At the end of the surgery and before Consciousness of the patient, the intervention will end and the patient will not be conscious of the type of intervention.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran university of Medical Sciences
Street address
dormitory complex number one for girls, Mazandaran University of Medical Sciences ( Payambar Azam Complex), Darya Road (Farahabad)
City
Sary
Province
Mazandaran
Postal code
4847193711
Approval date
2024-05-14, 1403/02/25
Ethics committee reference number
IR.MAZUMS.REC.1403.116

Health conditions studied

1

Description of health condition studied
cholecystectomy laparoscopic
ICD-10 code
K80.1
ICD-10 code description
Calculus of gallbladder with other cholecystitis

Primary outcomes

1

Description
Right and left shoulder pain
Timepoint
The moment of discharge from recovery, 6, 12, 24, 48 hours after surgery
Method of measurement
Visual analogue scale

2

Description
Chills in recovery
Timepoint
Entering recovery, 15 and 30 minutes after entering, the moment of discharge from recovery
Method of measurement
Criterion Crossley, Mahajan

3

Description
Changes in hemodynamic parameters
Timepoint
Before starting surgery, during surgery at intervals of 15 minutes, entering the recovery room, 15 and 30 minutes after entering the recovery room, the moment of discharge from the recovery room
Method of measurement
monitoring

4

Description
Temperatures
Timepoint
Before starting surgery, during surgery at intervals of 15 minutes, entering the recovery room, 15 and 30 minutes after entering the recovery room, the moment of discharge from the recovery room
Method of measurement
Tympanic thermometer

Secondary outcomes

1

Description
The amount of bleeding at the surgical site
Timepoint
End of surgery
Method of measurement
Interview with the surgeon

Intervention groups

1

Description
Intervention group A: Blowing warm carbon dioxide gas to create pneumoperitoneum
Category
Treatment - Surgery

2

Description
Intervention group B: Blowing carbon dioxide gas at operating room temperature to create pneumoperitoneum and placing a warm water bag in the common place of shoulder pain
Category
Treatment - Surgery

3

Description
Control group: Blowing carbon dioxide gas at operating room temperature to create pneumoperitoneum
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohaday Mehrab Hospital
Full name of responsible person
Saeedeh Vaziri
Street address
Moalem Square, Shahid Paknejad Blvd, Shohadaymehrab Hospital
City
Yazd
Province
Yazd
Postal code
8917615469
Phone
+98 35 3525 0093
Email
yazd_burn_ssu@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Research and Technology Deputy Building, Moalem Square, Sary Town
City
Sary
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd Shohaday Mehrab Hospital
Proportion provided by this source
40
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
Saeedeh Vaziri
Position
Master of Science student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No. 41, Mohamad Yazdy Ave, Hefdeh Shahrivar Blve
City
Yazd
Province
Yazd
Postal code
8917716730
Phone
+98 35 3526 4582
Fax
Email
saeedeh.vaziri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ibrahim Nasiri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Paramedicine, Mazandaran University of Medical Sciences, Farah Abad Blvd (Darya Road), Khazar Square, Sary Town
City
Sary
Province
Mazandaran
Postal code
4847193711
Phone
+98 11 3354 3246
Email
Pirapezeshkisari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Saeedeh Vaziri
Position
Master of Science student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No. 41, Mohamad Yazdy Ave, Hefdeh Shahrivar Blve
City
Yazd
Province
Yazd
Postal code
8917716730
Phone
+98 35 3526 4582
Fax
Email
saeedeh.vaziri@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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