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

Nausea and Vomiting, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05426278
• Other study ID #: 2022-7343-21332
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: June 2022
• Source: Aga Khan University
• Contact: Tashfain Bin Zafar, MBBS
• Phone: +92 3362459094
• Email: tashfain.zafar[@]aku.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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• Patients will be withdrawn from the group if their laparoscopy is converted to open surgery

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia; Anesthesia
• Nausea
• Nausea and Vomiting, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

References & Publications (4)

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. — View 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. Review. — View Citation

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

Torossian A, Bräuer A, Höcker 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1
Primary	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	Day 1