Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04252820
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2020-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'C000721827', 'term': 'Transurethral resection syndrome'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Randomization will be carried out by a collaborator investigator using a computer program (Excel 2016) when a new patient is included into the clinical trial. This collaborator investigator will tell the nurse in charge of receiving the patient in the preanesthetic room how long prewarming has to be given to the patient: 0 minutes (no prewarming), 15 minutes, 30 minutes or 45 minutes, according to the group given by the computer program. This collaborator investigator will not provide clinical care to the patient. Attending anesthesiologist will be blind to the allocation of the participants. Principal investigator will not be able to know how long prewarming will be given.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Different time periods of prewarming will be compared: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor', 'timeFrame': 'Throughout surgery, an average of 60 minutes.', 'description': 'To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection under spinal anesthesia'}], 'secondaryOutcomes': [{'measure': 'Length of stay in postanesthetic care unit (in minutes)', 'timeFrame': 'Stay in Post-Anesthetic Care Unit, an average of 6 hours.', 'description': '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.'}, {'measure': 'Postoperative pain, using visual analogue scale (from 0 to 10)', 'timeFrame': 'Immediate postoperative period, an average of 1 hour.', 'description': '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'}, {'measure': 'Postoperative shivering (using a dichotomous scale: yes or no)', 'timeFrame': 'Immediate postoperative period, an average of 1 hour', 'description': 'To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection under spinal anesthesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['body temperature', 'hypothermia', 'prewarming', 'regional anesthesia'], 'conditions': ['Hypothermia; Anesthesia', 'Perioperative Complication', 'Regional Anesthesia Morbidity', 'Temperature Change, Body', 'Transurethral Resection Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Inadvertent perioperative hypothermia is probably the most common anaesthetic complication. Its appearance increases the morbidity of the surgical patient, increasing the incidence of cardiac events or perioperative blood loss and causes a greater time of recovery from anaesthesia. Prewarming is the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, prewarming in patients submitted to spinal anesthesia is still a weak recommendation and the optimal prewarming time has not been elucidated. Due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection under spinal anaesthesia, the conductance of this clinical trial is justified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective Transurethral resection under spinal anesthesia.\n* Patients older tan 18 years old.\n* American Society of Anesthesiologists physical status classification I - III.\n* Absence of cognitive impairment.\n* Written informed consent before enrollment.\n\nExclusion Criteria:\n\n* Pregnancy.\n* American Society of Anesthesiologists physical status classification IV.\n* Active infection.\n* Intake of antipyretics within 24 hours before surgery.\n* Thyroid disorders.\n* Skin lesions or History of hypersensitivity to skin contact devices.'}, 'identificationModule': {'nctId': 'NCT04252820', 'briefTitle': 'Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Dr. Negrin University Hospital'}, 'officialTitle': 'Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia', 'orgStudyIdInfo': {'id': 'RTU-Spinal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No prewarming. Patients will be actively warmed during the intraoperative period. Tympanic thermometer and zero-heat-flux temperature sensor will be used to measure the temperature throughout the perioperative period.'}, {'type': 'EXPERIMENTAL', 'label': 'Prewarming during 15 minutes', 'description': 'Active Prewarming will be performed during 15 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period.', 'interventionNames': ['Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA']}, {'type': 'EXPERIMENTAL', 'label': 'Prewarming during 30 minutes', 'description': 'Active Prewarming will be performed during 30 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period.', 'interventionNames': ['Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA']}, {'type': 'EXPERIMENTAL', 'label': 'Prewarming during 45 minutes', 'description': 'Active Prewarming will be performed during 45 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period.', 'interventionNames': ['Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA']}], 'interventions': [{'name': 'WarmTouch total body blanket, Covidien Ltd, Mansfield, USA', 'type': 'DEVICE', 'description': 'Forced-air warming will be applied in the preanesthetic room', 'armGroupLabels': ['Prewarming during 15 minutes', 'Prewarming during 30 minutes', 'Prewarming during 45 minutes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35019', 'city': 'Las Palmas de Gran Canaria', 'state': 'Las Palmas', 'country': 'Spain', 'facility': 'Ángel Becerra', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}], 'overallOfficials': [{'name': 'Aurelio Rodríguez-Pérez, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dr Negrin UH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data are to be shared with other researchers when required once the study is completed and global data are published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Negrin University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Anesthesiologist', 'investigatorFullName': 'Ángel Becerra', 'investigatorAffiliation': 'Dr. Negrin University Hospital'}}}}