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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05426278
Other study ID # 2022-7343-21332
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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disease - Heart failure - ASA Category 3&4 (American Society of Anaesthesiologist Classification) - Patients will be withdrawn from the group if their laparoscopy is converted to open surgery

Study Design


Related Conditions & MeSH terms


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
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