Regional Anesthesia Morbidity Clinical Trial
Official title:
Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
NCT number | NCT04252820 |
Other study ID # | RTU-Spinal |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | August 4, 2020 |
Verified date | August 2020 |
Source | Dr. Negrin University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Perioperative hypothermia is one of the most common anaesthetic complications, increasing the morbidity/mortality of our patients. Active prewarming with hot forced-air devices has demonstrated to be the most effective tool to prevent hypothermia, but its use is only recommended in long-term surgeries and the optimal prewarming duration has not been elucidated. Both spinal anaesthesia associated to the irrigation with liquids at low temperature instilled during transurethral resection (TUR) cause a decrease in the core temperature of the patient. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. Our aim is to assess the effect of different time-periods of prewarming on preventing perioperative hypothermia during TUR with spinal anaesthesia. Investigators will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 200 patients are going to be included in this study (50 patients in each group). Measurement of temperature will be performed using a tympanic thermometer and zero-heat-flux temperature sensor. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.
Status | Completed |
Enrollment | 215 |
Est. completion date | August 4, 2020 |
Est. primary completion date | August 4, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients undergoing elective Transurethral resection under spinal anesthesia. - Patients older tan 18 years old. - American Society of Anesthesiologists physical status classification I - III. - Absence of cognitive impairment. - Written informed consent before enrollment. Exclusion Criteria: - Pregnancy. - American Society of Anesthesiologists physical status classification IV. - Active infection. - Intake of antipyretics within 24 hours before surgery. - Thyroid disorders. - Skin lesions or History of hypersensitivity to skin contact devices. |
Country | Name | City | State |
---|---|---|---|
Spain | Ángel Becerra | Las Palmas De Gran Canaria | Las Palmas |
Lead Sponsor | Collaborator |
---|---|
Dr. Negrin University Hospital |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor | To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection under spinal anesthesia | Throughout surgery, an average of 60 minutes. | |
Secondary | Length of stay in postanesthetic care unit (in minutes) | To assess the effect of prewarming in the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection under spinal anesthesia. | Stay in Post-Anesthetic Care Unit, an average of 6 hours. | |
Secondary | Postoperative pain, using visual analogue scale (from 0 to 10) | To assess the effect of prewarming in reducing the postoperative pain at the arrival to the postanesthetic care unit of patients undergoing elective transurethral resection under spinal anesthesia | Immediate postoperative period, an average of 1 hour. | |
Secondary | Postoperative shivering (using a dichotomous scale: yes or no) | To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection under spinal anesthesia | Immediate postoperative period, an average of 1 hour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06005480 -
Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04565093 -
Efficacy of iPACK After Unilateral TKA
|
N/A | |
Recruiting |
NCT06074471 -
Motor Sparing Supraclavicular Block
|
N/A | |
Completed |
NCT03740815 -
Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection
|
N/A | |
Completed |
NCT02524652 -
Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction
|
Phase 4 | |
Completed |
NCT03913429 -
Ultrasound-guided Bilateral Suprazygomatic Maxillary Nerve Block and Bimaxillary Osteotomy
|
N/A | |
Completed |
NCT05012332 -
Local Anesthesia Spread After an Erector Spinae Plane Block.
|
N/A | |
Withdrawn |
NCT04015284 -
Intraoperative Pain and Quality of Surgical Block During Shoulder Surgery Assessed by NOL Index
|
N/A | |
Recruiting |
NCT05432934 -
Transversus Abdominis Plane Blocks With and Without Dexamethasone
|
Phase 1/Phase 2 | |
Recruiting |
NCT05512897 -
Does ESP Block Reduce Pain and Opiates Consumption After Surgery
|
N/A | |
Completed |
NCT04085263 -
Rhomboid Intercostal and Subserratus Plane Block
|
N/A | |
Not yet recruiting |
NCT04001387 -
Feasibility of Real-time Ultrasound-guided Spinal Anesthesia Using Dynamic Needle Tip Positioning
|
||
Active, not recruiting |
NCT05478629 -
Safety of Regional Anesthesia in Ukraine: the Survey
|
||
Terminated |
NCT03296033 -
Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin
|
Phase 4 | |
Withdrawn |
NCT02603900 -
Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT03666845 -
Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease
|
||
Completed |
NCT03394807 -
LaGRA Trial in Laparoscopic Cholecystectomy
|
Phase 4 | |
Completed |
NCT05558449 -
Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia
|
Phase 4 | |
Completed |
NCT02433561 -
Intra- Versus Extraplexic Catheter Placement for Continuous Interscalene Brachial Plexus Block
|
Phase 4 | |
Recruiting |
NCT06147401 -
Comparison of PENG Associated With LFCN Block Versus FICB for Multimodal Analgesic Management in THA
|
N/A |