Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-22 @ 7:03 PM
Study NCT ID:
NCT03643666
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2018-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-03', 'studyFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain: VAS', 'timeFrame': 'first 24 hours', 'description': 'Postoperative pain scoring using standard Visual Analogue Scale (VAS) pain score of 0-10 (with 0 meaning no pain and 10 meaning the most intense pain ever experienced)'}], 'secondaryOutcomes': [{'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'first 24 hours', 'description': 'Postoperative nausea and vomiting using simplified simplified postoperative nausea and vomiting (PONV) impact scale which is measured through two questions as following:\n\nQ1. Has the patient vomited or had dry-retching? 0. No\n\n1. Once\n2. Twice\n3. Three or more times Q2. Has the patient experienced a feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit)? If yes, has the feeling of nausea interfered with activities of daily life, such as being able to get out of bed, being able to move about freely in bed, being able to walk normally, or eating and drinking?\n\n0\\. Not at all\n\n1. Sometimes\n2. Often or most of the time\n3. All of the time. To calculate the PONV Impact Scale, the numerical responses to questions 1 and 2 will be added. Several vomits or dry-retching events occurring over a short time frame e.g 5 min, will be counted as one vomiting/dry-retching episode.'}, {'measure': 'Heart rate', 'timeFrame': 'first 24 hours'}, {'measure': 'arterial blood pressure measurement postoperative', 'timeFrame': 'first 24 hours', 'description': 'systolic and diastolic blood pressure'}, {'measure': 'doses of consumed postoperative analgesics', 'timeFrame': 'first 24 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Laparoscopic cholecystectomy has become a standard technique for gall bladder surgery. Benefits in comparison to conventional laparotomy are shorter lived effects on pulmonary function and less postoperative pain . However, patients often suffer from considerable pain during the first 24 postoperative hours. Pain can prolong hospital stay and lead to increased morbidity, which is particularly important now that many centers are performing this operation as a day-case procedure. Administration of intraperitoneal local anesthetic, either during or after surgery, is used by as a method of reducing postoperative pain. Although a number of studies have reported a significant reduction in postoperative pain after the use of intraperitoneal analgesia, others have reported no benefit. Several investigations have been conducted in order to find the cause of this pain. According to some of these investigations, the pain is attributed to peritoneal inflammation due to carbon dioxide pneumoperitoneum. Since steroids have been used for reducing inflammation, they may be considered as alternatives for relieving pain. Dexamethasone is a strong long acting glucocorticoid and it is widely used after surgery. it has been established that steroids are effective in relieving postoperative pain in laparoscopic cholecystectomy. Also, administration of magnesium sulphate has been shown to have a potential to prevent postoperative pain and to reduce intra operative anesthetic and analgesic requirements being an antagonist of N-methyl-D-aspartate (NMDA) receptors and its associated ion channels. Some studies showed reduction of pain scores if magnesium sulphate was injected intra-articular and intraperitoneal with no serious adverse effects. In this study the investigators will use intraperitoneal dexamethasone vs dexamethasone plus magnesium sulphate to study their analgesic efficacy after laparoscopic cholecystectomy as the investigators assume that the combination of both drugs will provide stronger analgesia than dexamethasone alone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age group and gender: between 18 to 60 years both males and females\n2. American Society of Anesthesiologists (ASA) physical status I-II\n\nExclusion Criteria:\n\n1. Age \\< 18 years or \\> 60 years\n2. ASA physical status III or IV\n3. Patients with diabetes\n4. Patient refusal to participate in the study\n5. Chronic respiratory disease\n6. Advanced renal or hepatic diseases\n7. Use of opioids, tranquilizers or steroids\n8. Confusion or psychiatric illness\n9. Acute cholecystectomy\n10. Patients with peritoneal drain after surgery'}, 'identificationModule': {'nctId': 'NCT03643666', 'briefTitle': 'Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic cholecystectomY', 'orgStudyIdInfo': {'id': 'N-9-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'this group will include 25 patients receiving intraperitoneal 40 ml of normal saline only at the end of laparoscopic cholecystectomy', 'interventionNames': ['Drug: Placebo (saline)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexamethasone group', 'description': 'this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone in 40 ml saline at the end of laparoscopic cholecystectomy', 'interventionNames': ['Drug: dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexamethasone plus magnesium sulphate group', 'description': 'this group will include 25 patients receiving intraperitoneal 16 mg dexamethasone plus 2 gm magnesium sulphate at the end of laparoscopic cholecystectomy', 'interventionNames': ['Drug: dexamethasone', 'Drug: magnesium sulphate']}], 'interventions': [{'name': 'dexamethasone', 'type': 'DRUG', 'description': 'before closure of the laparoscopic entering sites the patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone', 'armGroupLabels': ['dexamethasone group', 'dexamethasone plus magnesium sulphate group']}, {'name': 'magnesium sulphate', 'type': 'DRUG', 'description': 'patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone plus magnesium sulphate 2 gm into the peritoneum at the end of the operation', 'armGroupLabels': ['dexamethasone plus magnesium sulphate group']}, {'name': 'Placebo (saline)', 'type': 'DRUG', 'description': 'before closure of the laparoscopic entering sites the patients received instillation of 40 ml normal saline into the peritoneum', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alaini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'AbdElKhalik Mahmoud Shaban', 'investigatorAffiliation': 'Cairo University'}}}}