Comparison the effect of two methods of warming on the physiological indices during and after laparoscopic abdominal surgery at the Alzahra Hospital of Isfahan in 2017
Objective: comparison the effect of two methods of warming on the physiological indices during and after laparoscopic abdominal surgery. Study design: stratified random sampling. Study population: patients with laparoscopic cholecystectomy in Al-Zahra hospital. The main inclusion criteria: no underlying disease and cardiovascular disease; no fever; aged between 18 and 65 years; surgery time up to 2 hours. The main exclusion criteria: need for blood transfusions during and after surgery; intra-abdominal infections; get more than 5 liters of intravenous fluids during surgery. Sample size: 96 patients. Intervention or interventions: the patients to a separate procedure will be warm. Intervention time: immediately after induction of anesthesia, extremities of the patient in the 1 group is heated by the forced air system, warming IV fluids are used for the group 2 until 30 minutes after the end of the surgery. The control group received routine care. Variables before induction of anesthesia, immediately after induction of anesthesia and every 15 minutes until 30 minutes after the end of the surgery will be measured. Intensity of shivering in recovery with an anesthesiologist monitoring and verification by means of observation (Grossley and Mahajan) will be examined. The primary outcome or consequences of the study: changes in physiological parameters and reduce shivering.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041533435N1
Registration date:2017-05-16, 1396/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-16, 1396/02/26
Registrant information
Name
Fereshteh Baradaran Fard
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7565
Email address
baradaranfard.f@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2017-03-08, 1395/12/18
Expected recruitment end date
2017-07-09, 1396/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two methods of warming on the physiological indices during and after laparoscopic abdominal surgery at the Alzahra Hospital of Isfahan in 2017
Public title
Comparison the effect of two methods of warming on the physiological indices during and after laparoscopic abdominal surgery at the Alzahra Hospital of Isfahan in 2017
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: satisfaction; no underlying disease (hypothyroidism, hyperthyroidism, diabetes and hypertension) and cardiovascular disease; no fever; aged between 18 and 65 years; surgery time up to 2 hours; no received Corticosteroids and non-steroidal anti-pain; lack of infection; ASA = I - II; BMI = 18.5 - 38.
The exclusion criteria: the need for open surgery or return the patient to the operating room; and said heat felt by the patient in recovery; need for blood transfusions during and after surgery; intra-abdominal infections; blood loss during surgery more than 1 liter; Sensitivity to anesthetic drugs; get more than 5 liters of intravenous fluids during surgery; temperature more than 37.5 or less than 36.5 prior to surgery; the need for cardiopulmonary resuscitation during surgery; intraoperative hemodynamic changes include a severe drop in blood pressure and pulse; using humid and warm CO2 gas for pneumoperitoneum.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University Of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Postal code
81746-73465
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
IR.MUI.REC.1390.30947
Health conditions studied
1
Description of health condition studied
hypothermia and Shivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Core body temperature
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until 30 minutes after the end of surgery.
Method of measurement
Tympanic thermometers
2
Description
blood pressure
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until 30 minutes after the end of surgery.
Method of measurement
Blood Pressure Monitor (monitoring vital signs)
3
Description
pulse
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until 30 minutes after the end of surgery.
Method of measurement
Pulse oximetry (monitoring vital signs)
4
Description
respiratory rate
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until 30 minutes after the end of surgery.
Method of measurement
Counting (monitoring vital signs)
5
Description
oxygen saturation
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until 30 minutes after the end of surgery.
Method of measurement
Pulse oximetry (monitoring vital signs)
6
Description
Shivering
Timepoint
after surgery
Method of measurement
Visual assessment scale
Secondary outcomes
1
Description
Duration of anesthesia
Timepoint
after suegery
Method of measurement
Since the induction of anesthesia until extubation
2
Description
intravenous fluids
Timepoint
after suegery
Method of measurement
Observation
3
Description
Duration of surgery
Timepoint
after suegery
Method of measurement
from making the surgical incision to skin closure and dressing
4
Description
pneumoperitoneum time
Timepoint
after suegery
Method of measurement
Since the introduction of gas into the abdomen until removing it from the abdomen
5
Description
The volume of carbon dioxide input
Timepoint
after suegery
Method of measurement
Observation
Intervention groups
1
Description
Patients immediately after induction of anesthesia under a forced air system with maximum temperature will be 45 ° C.
Category
Prevention
2
Description
Warming IV fluids (38 ° C) is recommended immediately after induction of anesthesia
Category
Prevention
3
Description
Control group receive routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital of Isfahan
Full name of responsible person
Fereshteh Baradaran Fard
Street address
Soffeh Blvd., Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Akram Aarabi
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fereshteh Baradaran Fard
Position
A graduate student in the operating room
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7510
Fax
Email
baradaranfard.f@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Akram Aarabi
Position
University faculty member
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran
City
Isfahan
Postal code
Phone
+98 31 3792 7510
Fax
Email
aarabi@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)