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Clinical Trials/NCT05426278
NCT05426278UnknownNot Applicable

The Effect Of Intraoperative Forced Air Warmer Use, On Postoperative Nausea And Vomiting Among Laparoscopic Surgery Patients: A Randomized Controlled Trial

Aga Khan University0 sites86 target enrollmentStarted: October 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
86
Primary Endpoint
Post Operative Nausea Vomiting Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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  • •Patients will be withdrawn from the group if their laparoscopy is converted to open surgery

Arms & Interventions

FAW and Bair Hugger Group

Other

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

Intervention: Bair hugger and Forces air warmer (Device)

Control group

No Intervention

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

Outcomes

Primary Outcomes

Post Operative Nausea Vomiting Scale

Time Frame: Day 1

The scores of 0-3 will determine severity on the Post-operative nausea and vomiting scale. 0 - No nausea , No vomiting 1. - Nausea present , No Vomiting 2. - Nausea present , Vomiting present 3. - Vomiting \>2 episodes within 30 minutes

Bedside Shivering Assessment Scale (BSAS)

Time Frame: 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 1. -(mild) Shivering localized to Neck and thorax only 2. -(moderate) Shivering involves gross movement of the upper extremities( in addition to neck and thorax) 3. -(severe) Shivering involves gross movements of the trunk and upper and lower extremities

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammad Hamid

Associate professor

Aga Khan University

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