Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-31 @ 12:27 PM
Study NCT ID:
NCT05752734
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2023-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Dexamethasone to Improve Quality of Recovery After Laparoscopic Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2023-02-21', 'studyFirstSubmitQcDate': '2023-02-21', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Quality of Recovery (QoR-40) score in the first 24 hours after surgery', 'timeFrame': 'postoperative day 1', 'description': 'The recovery quality of the patients 24 hours after the operation will be evaluated with the QoR-40 questionnaire. The questionnaire consists of 40 questions that examine five domains of patient recovery using a five point Likert scale: none of the time, some of the time, usually, most of the time, and all of the time. The five domains include physical comfort, pain, physical independence, psychological support, and emotional state.\n\nAs a result of the evaluation, the total score ranges from 40 (worst review quality score) to 200 (best review quality score).'}, {'measure': 'The score for each of the five parameters that make up the QoR-40 questionnaire', 'timeFrame': 'postoperative day 1', 'description': 'It consists of 5 parameters: physical independence score (n = 5), patient support score (n = 7), Physical comfort score (n = 12), emotional state score (n = 9) and pain score (n = 7).'}], 'secondaryOutcomes': [{'measure': 'Morphine consumption in the first 24 hours after surgery', 'timeFrame': 'postoperative day 1', 'description': 'Morphine consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score ≥3.'}, {'measure': 'The incidences of post-operative nausea and vomiting (PONV)', 'timeFrame': 'postoperative day 1', 'description': 'Post-operative nausea and vomiting (PONV) will be evaluated with a verbal descriptive scale.\n\n(0 = None at all, 1 = Mild nausea, 2 = Moderate nausea, 3 = Vomiting once, 4 = Vomiting more than once)'}, {'measure': 'Time to first mobilization', 'timeFrame': 'Up to 24 hours after surgery.', 'description': 'The patients first mobilization time after the operation will be recorded.'}, {'measure': 'Time to discharge', 'timeFrame': 'Trough hospital stay, an average of 1 week', 'description': 'The length of hospital stay will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexamethasone', 'quality of recovery-40', 'acute pain scores', 'morphine consumption'], 'conditions': ['Anesthesia', 'Analgesia', 'Acute Pain']}, 'descriptionModule': {'briefSummary': 'In the obese patient, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea and vomiting, as well as analgesia. In our study, our aim is to evaluate the effect of dexamethasone added to multimodal analgesia on postoperative patient comfort in the obese patient group with a 40-item scale.', 'detailedDescription': 'Postoperative pain prolongs hospital stay, delays wound healing, increases infection rates, and increases the incidence of drug side effects due to the use of systemic pain relievers (especially opioids).\n\nGood pain control facilitates respiratory effort, allows the patient to perform respiratory exercises and cough to correct the increased thoracic fat mass and impaired respiratory mechanics due to anesthesia. The patient without pain is mobilized early and discharged early.\n\nOur aim is to evaluate the effect of dexamethasone added to multimodal analgesia on postoperative patient comfort in the obese patient group with a 40-item scale.\n\nPatients will be divided in to two groups (group D and group C):\n\nGroup D (Dexamethasone Group):\n\nPatients who used/applied dexamethasone before bariatric surgery were included in this group.\n\nGroup C(Control Group):\n\nPatients who did not use dexamethasone or steroid-derived drugs were included in this group.\n\nThe patients included in the study were evaluated with the 40-item recovery quality scale (QoR-40) 24 hours after the operation.\n\nİn addition all patients will be administered iv morphine pca (patient controlled analgesia) for the first 24 hours postoperatively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with BMI \\> 30 undergoing elective laparoscopic sleeve gastrectomy (LSG)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index\\>30 kg/m2\n* The American Society of Anaesthesiologists (ASA) physical status class I, II\n* The American Society of Anaesthesiologists (ASA) physical status class III only because of morbid obesity\n* Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)\n* Those who are literate enough to answer the compilation quality score (QoR-40) questionnaire\n\nExclusion Criteria:\n\n* refusal to participate\n* allergy to the study drugs\n* chronic kidney disease (creatinine\\>150 μmol/L)\n* mental illness\n* liver, respiratory or oncological disease,\n* cardiac dysfunction (ejection fraction \\<40%),\n* uncontrolled hypertension,\n* preoperative analgesic use,\n* chronic pain,\n* history of alcohol or drug addiction'}, 'identificationModule': {'nctId': 'NCT05752734', 'briefTitle': 'Preoperative Dexamethasone to Improve Quality of Recovery After Laparoscopic Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Preoperative Dexamethasone Enhances Quality of Recovery After Laparoscopic Bariatric Surgery: A Prospective Observational Study', 'orgStudyIdInfo': {'id': 'SLGQR402022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group D', 'description': 'Patients who used/applied dexamethasone before bariatric surgery were included in this group.', 'interventionNames': ['Drug: Group D']}, {'label': 'Group C', 'description': 'Patients who did not use dexamethasone or steroid-derived drugs were included in this group.', 'interventionNames': ['Drug: Group C']}], 'interventions': [{'name': 'Group D', 'type': 'DRUG', 'otherNames': ['dexamethasone group'], 'description': 'Patients who received 8 mg dexamethasone before bariatric surgery will be included in this group.\n\nMultimodal analgesia protocol is applied to all patients undergoing bariatric surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg, tramadol 100mg after induction of general anesthesia, and iv morphine (0.05mg/kg/IBW) intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv pca of 0,4mg/ml morphine (the bolus dose is 1mg, the lock-in time of 15 minutes, the 4-hour limit is adjusted to be 40% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥3) 0.5 mg/kg tramadol is administered to patients. For postoperative nausea and vomiting prophylaxis, patients are routinely administered ondansetron 4 mg IV 20 minutes before extubation.', 'armGroupLabels': ['Group D']}, {'name': 'Group C', 'type': 'DRUG', 'otherNames': ['control group'], 'description': 'Patients not administered dexamethasone will be included in this group.\n\nMultimodal analgesia protocol is applied to all patients undergoing bariatric surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg, tramadol 100mg after induction of general anesthesia, and iv morphine (0.05mg/kg/IBW) intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv pca of 0,4mg/ml morphine (the bolus dose is 1mg, the lock-in time of 15 minutes, the 4-hour limit is adjusted to be 40% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥3) 0.5 mg/kg tramadol is administered to patients. For postoperative nausea and vomiting prophylaxis, patients are routinely administered ondansetron 4 mg IV 20 minutes before extubation.', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55060', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuzmayıs University', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Yasemin Burcu Üstün', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yasemin Burcu Ustun', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}