The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting

Sponsor
Aga Khan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05426278
Collaborator
(none)
86
2
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Bair hugger and Forces air warmer
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 groups will be made - One group will be interventional and the Other will be the Control group2 groups will be made - One group will be interventional and the Other will be the Control group
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting Among Laparoscopic Surgery Patients: A Randomized Controlled Trial
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: FAW and Bair Hugger Group

Group B, the intervention group (with FAW and Bair Hugger).

Device: Bair hugger and Forces air warmer
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

No Intervention: Control group

Group A, the control group (No FAW or Bair Hugger)

Outcome Measures

Primary Outcome Measures

  1. Post Operative Nausea Vomiting Scale [Day 1]

    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

  2. Bedside Shivering Assessment Scale (BSAS) [Day 1]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Aga Khan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohammad Hamid, Associate professor, Aga Khan University
ClinicalTrials.gov Identifier:
NCT05426278
Other Study ID Numbers:
  • 2022-7343-21332
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2022