The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting
Primary Purpose
Hypothermia; Anesthesia, Nausea and Vomiting, Postoperative
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bair hugger and Forces air warmer
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia; Anesthesia
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing laparoscopic surgeries (Hernia Repair, Cholecystectomy, Appendectomy, Hysterectomy)
- ASA Category I and II as per American Society of Anaesthesiologist Classification.
- BMI< 35 kg/m2
- Duration of surgery >1 hour and <3 hours
- Patients who consent their participation
Exclusion Criteria:
- Temperature >37.5oC or <35oC,
- Chronic kidney disease
- Heart failure
- ASA Category 3&4 (American Society of Anaesthesiologist Classification)
- Patients will be withdrawn from the group if their laparoscopy is converted to open surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
FAW and Bair Hugger Group
Control group
Arm Description
Group B, the intervention group (with FAW and Bair Hugger).
Group A, the control group (No FAW or Bair Hugger)
Outcomes
Primary Outcome Measures
Post Operative Nausea Vomiting Scale
The scores of 0-3 will determine severity on the Post-operative nausea and vomiting scale.
0 - No nausea , No vomiting
- Nausea present , No Vomiting
- Nausea present , Vomiting present
- Vomiting >2 episodes within 30 minutes
Bedside Shivering Assessment Scale (BSAS)
The scores of 0-3 will determine severity on Shivering
0 -(none) No shivering is detected on palpation of masseter, Neck, or chest muscles
-(mild) Shivering localized to Neck and thorax only
-(moderate) Shivering involves gross movement of the upper extremities( in addition to neck and thorax)
-(severe) Shivering involves gross movements of the trunk and upper and lower extremities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05426278
Brief Title
The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting
Official Title
The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting Among Laparoscopic Surgery Patients: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Intraoperative Hypothermia is a common problem, our object will be to evaluate the efficacy of forced air warmer (Model # eq-5000) for maintaining core body temperature in patients undergoing laparoscopic surgeries and its effect on postoperative nausea, vomiting and shivering.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia, Nausea and Vomiting, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups will be made - One group will be interventional and the Other will be the Control group
Masking
Participant
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FAW and Bair Hugger Group
Arm Type
Other
Arm Description
Group B, the intervention group (with FAW and Bair Hugger).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Group A, the control group (No FAW or Bair Hugger)
Intervention Type
Device
Intervention Name(s)
Bair hugger and Forces air warmer
Intervention Description
The EQUATOR™ (EQ-5000) air-warmer is a convective warmer, with the average and maximum Contact Surface Temperatures of 39℃ & 44℃ Respectively. Temperature on this device can be set at 36℃ , 40℃ , 44℃. The 3M™ Bair Hugger ™ (SW-2003) upper body blanket is used to warm the body from head till the xiphisternum
Primary Outcome Measure Information:
Title
Post Operative Nausea Vomiting Scale
Description
The scores of 0-3 will determine severity on the Post-operative nausea and vomiting scale.
0 - No nausea , No vomiting
- Nausea present , No Vomiting
- Nausea present , Vomiting present
- Vomiting >2 episodes within 30 minutes
Time Frame
Day 1
Title
Bedside Shivering Assessment Scale (BSAS)
Description
The scores of 0-3 will determine severity on Shivering
0 -(none) No shivering is detected on palpation of masseter, Neck, or chest muscles
-(mild) Shivering localized to Neck and thorax only
-(moderate) Shivering involves gross movement of the upper extremities( in addition to neck and thorax)
-(severe) Shivering involves gross movements of the trunk and upper and lower extremities
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing laparoscopic surgeries (Hernia Repair, Cholecystectomy, Appendectomy, Hysterectomy)
ASA Category I and II as per American Society of Anaesthesiologist Classification.
BMI< 35 kg/m2
Duration of surgery >1 hour and <3 hours
Patients who consent their participation
Exclusion Criteria:
Temperature >37.5oC or <35oC,
Chronic kidney disease
Heart failure
ASA Category 3&4 (American Society of Anaesthesiologist Classification)
Patients will be withdrawn from the group if their laparoscopy is converted to open surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tashfain Bin Zafar, MBBS
Phone
+92 3362459094
Email
tashfain.zafar@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Hamid, MD
Phone
+92 3002412205
Email
mohammad.hamid@aku.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25837741
Citation
Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.
Results Reference
background
PubMed Identifier
29726859
Citation
Pyzocha NJ, Steele JL. Hypothermia in adults: A strategy for detection and Tx. J Fam Pract. 2018 May;67(5):E1-E7.
Results Reference
background
PubMed Identifier
18330074
Citation
Putzu M, Casati A, Berti M, Pagliarini G, Fanelli G. Clinical complications, monitoring and management of perioperative mild hypothermia: anesthesiological features. Acta Biomed. 2007 Dec;78(3):163-9.
Results Reference
background
PubMed Identifier
33053048
Citation
Liang D, Shan Y, Wang L. The effect of prophylactic rewarming on postoperative nausea and vomiting among patients undergoing laparoscopic hysterectomy: a prospective randomized clinical study. Sao Paulo Med J. 2020 Sep-Oct;138(5):414-421. doi: 10.1590/1516-3180.2020.0059.R2.06072020.
Results Reference
background
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The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting
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