Clinical trial NCT02243462: Preoperative Warming and Perioperative Shivering
Official title: Effectiveness of Pre-operative Warming in Prevention of Peri-operative Shivering
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Forced Air Warming Effect on Hypothermia
Keywords: Shivering
Hypothermia
Postoperative
Temperature
Forced air warmer
Lead sponsor: Indus Hospital and Health Network
Sponsor class: OTHER
First posted: 2014-09-18
Enrollment: 180
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Shivering is one of the most commonly recognized problem associated with anesthesia, It is believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.

Forced air warmers are the most frequently used active warming devices in the peri-operative setting. Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.

Detailed description: Inadvertent peri-operative hypothermia (IPH) and shivering is one of the most commonly recognized problem during anesthesia which is believed to be thermoregulatory in origin. Although shivering is uncomfortable for most patients, it is unlikely that this relatively small increase in total body oxygen consumption in the average shivering patient is associated with increased peri-operative morbidity. It is common for patients to complain that their worst memory from the recovery room is the intense cold sensation and uncontrollable shivering. New guidelines recommend that patients core temperature has to be maintained at \>36°C, postoperatively. Studies suggest that pre-warming the patient prior to the surgery can reduce the chances of hypothermia induced shivering during the post operative period.

Forced air warmers are the most frequently used active warming devices in the peri-operative setting. They are effective at preventing hypothermia induced shivering when used before induction of anesthesia, during anesthesia and surgery, and after emergence in the post-anesthesia care unit. Other methods such as warm fluids, opioids, blankets and warm light devices can be used but are less effective as compared to the forced air warming devices.

Currently, our hospital does not pre-warm patients but if our study shows that pre-warming reduces post-operative shivering, we will be able to make an evidence based decision to start this practice.

Eligibility criteria: Inclusion Criteria:

* All patients going under therapeutic laparoscopic surgery
* All patients between 15-70 years irrespective of their gender
* ASA 1-3 patients
* Those who have given informed consent

Exclusion Criteria:

* Any patient undergoing diagnostic laparoscopic surgery
* Patients below age of 15 yrs
* ASA 4 or higher patients
* Patients not giving informed consent

Primary outcomes:
measure: inadvertent shivering post surgery
timeFrame: upto 2-3 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Indus Hospital
state: Sind
Study officials:
affiliation: The Indus Hospital
name: Ali Asghar, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Indus Hospital
name: Shahid Amin
role: STUDY_DIRECTOR
References: