A study to compare two techniques of warming the patient with warm air (starting warming 1 h before anesthesia and starting warming with start of anesthesia) to prevent reduction in patients body temperature during the surgery

Not yet recruiting

Conditions: Patients undergoing elective laparotomy under general anaesthesia with expected duration of more than 2 hrs

Registration Number: CTRI/2016/10/007418

Lead Sponsor: Kasturba Hospital Kasturba Medical College Manipal

Brief Summary: In this open label study two techniques of patient warming ( prewarming - convective warming beginning 1 hour before induction of anesthesia and extending into intraoperative period; cowarming - convective warming beginning with induction of anesthesia and extending into intraoperative period) will be compared to prevent intraoperative hypothermia. Included patients (approximately 60 in number) will undergo matched randomization (matched with respect to the type of surgery) to group prewarming where patients are warmed with convective warmer 1 hour prior to anesthesia and group cowarming where the convective warming begins along with the induction of general anesthesia. In both the groups warming continues into the intraoperative period till the end of the surgery. The primary outcome measure is the nasopharyngeal body temperature measured starting from induction of anesthesia, every 15 min till the end of the surgery. The secondary outcome measures are the axillary temperature measured starting from induction of anesthesia every 15 min till the end of surgery, patient comfort during prewarming in group prewarming, incidence of shivering during the first postoperative hour.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1)adult patients of either gender 2)age 18 to 65 years 3)ASA physical status 1 and 2 4)Body mass index of 18.5 to 25 5)undergoing elective laparotomy under general anaesthesia with expected duration of more than 2 hrs.

Exclusion Criteria

1.Patients suffering from endocrine disorders like thyroid disease, dysautotonia , Cushing syndrome, diabetes mellitus with autonomic neuropathy 2.Patients affected with peripheral vascular disease like Raynaudâ€™s syndrome 3.Critically ill or haemodynamically unstable patients who may require massive rapid intravenous fluid resuscitation 4.Febrile patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasopharyngeal temperature	every 15 min starting from induction of anesthesia till the end of surgery.

Secondary Outcome Measures

Name	Time	Method
axillary temperature	once in every 15 min after start of anesthesia till end of surgery
Comfort level of patient during prewarming	one point measurement after 1 hour of prewarming but just before induction of anesthesia
Shivering during first postoperative hour	one point assessment after 1 hour of surgery

Trial Locations

Locations (1): Kasturba Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
DR N Kalyan
Principal investigator
9663394716
kalyann45@gmail.com