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

NCT ID: NCT05426278

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothermia; Anesthesia Nausea and Vomiting, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups will be made - One group will be interventional and the Other will be the Control group
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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FAW and Bair Hugger Group

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

Group Type OTHER

Bair hugger and Forces air warmer

Intervention Type DEVICE

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Hamid

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tashfain Bin Zafar, MBBS

Role: CONTACT

+92 3362459094

Mohammad Hamid, MD

Role: CONTACT

+92 3002412205

References

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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.

Reference Type BACKGROUND
PMID: 25837741 (View on PubMed)

Pyzocha NJ, Steele JL. Hypothermia in adults: A strategy for detection and Tx. J Fam Pract. 2018 May;67(5):E1-E7.

Reference Type BACKGROUND
PMID: 29726859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18330074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33053048 (View on PubMed)

Other Identifiers

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2022-7343-21332

Identifier Type: -

Identifier Source: org_study_id

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