Spinal Diseases Clinical Trial
Official title:
Effect of Positive End Expiratory Pressure on Intraoperative Body Temperature in Patients Undergoing Spine Surgery; a Prospective Randomized Study
Intraoperative hypothermia is associated with many clinical adverse outcomes. Many techniques were applied to prevent intraoperative hypothermia, and positive end-expiratory pressure (PEEP) has been known to blunt intraoperative hypothermia by increasing thermoregulatory vasoconstriction threshold. The investigators assessed the effect of PEEP on the prevention of intraoperative hypothermia during spine surgery in prone position.
Status | Not yet recruiting |
Enrollment | 42 |
Est. completion date | July 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients who were scheduled for elective spine surgery requiring more than 3 hours Exclusion Criteria: - Patients who do not agree to the study - Patients with or American Society of Anesthesiologists (ASA) physical status class 3 or more - Patients with thyroid disease, peripheral vascular diseases, uncontrolled diabetes or hypertension - Patients with morbid obesity (BMI >35 kg/m2) - Patients with clinically severe pulmonary disease - Patients undergoing simultaneous anterior and posterior lumbar fusion surgery were also excluded. - Patients with taking non-steroidal anti-inflammatory drug within two weeks - Patients with preoperative fever or hypothermia - Patients with intraoperative intentional hypothermia for neuroprotection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University of Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Jung KT, Kim SH, Lee HY, Jung JD, Yu BS, Lim KJ, So KY, Lee JY, An TH. Effect on thermoregulatory responses in patients undergoing a tympanoplasty in accordance to the anesthetic techniques during PEEP: a comparison between inhalation anesthesia with desflurane and TIVA. Korean J Anesthesiol. 2014 Jul;67(1):32-7. doi: 10.4097/kjae.2014.67.1.32. Epub 2014 Jul 29. — View Citation
Nakajima Y, Mizobe T, Takamata A, Tanaka Y. Baroreflex modulation of peripheral vasoconstriction during progressive hypothermia in anesthetized humans. Am J Physiol Regul Integr Comp Physiol. 2000 Oct;279(4):R1430-6. — View Citation
Yamasaki H, Tanaka K, Funai Y, Suehiro K, Ikenaga K, Mori T, Osugi H, Nishikawa K. The impact of intraoperative hypothermia on early postoperative adverse events after radical esophagectomy for cancer: a retrospective cohort study. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):943-7. doi: 10.1053/j.jvca.2014.02.013. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body temperature as assessed by esophageal temperature probe | Body temperature is assessed by esophageal temperature probe. The investigators used body temperature at 180 minutes after anesthesia induction as a primary outcome | 180 minutes after the completion of anesthesia induction | No |
Secondary | Thermoregulatory vasoconstriction threshold | The time of the difference in skin temperature between forearm and fingertip becoming zero. | until 180 minutes after the completion of anesthesia induction | No |
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