[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653517":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":25,"studyPopulation":17,"armGroups":26,"interventions":39,"overallOfficials":49,"centralContacts":54,"locations":60,"responsibleParty":78,"collaborators":17,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":17,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":17,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":17,"overallStatus":100,"whyStopped":17,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Shaheed Mohtarma Benazir Bhutto Institue of Trauma","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of post-spinal anesthesia shivering","Shivering will be assessed after spinal anesthesia and the occurrence of post-spinal anesthesia shivering will be recorded.","immediately after spinal anesthesia until 90 minutes post-spinal anesthesia",[14],{"measure":15,"description":16,"timeFrame":12},"Severity of post-spinal anesthesia shivering","Severity of post-spinal anesthesia shivering will be assessed and recorded.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Two-arm randomized controlled trial comparing prophylactic intravenous ketamine and tramadol for prevention of post-spinal anesthesia shivering.","PREVENTION",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE","Post-spinal anesthesia shivering is a common and undesirable phenomenon in patients undergoing surgery under spinal anesthesia. This randomized controlled trial will compare the prophylactic use of low-dose intravenous ketamine and tramadol for prevention of post-spinal anesthesia shivering in orthopedic surgical patients. A total of 106 ASA I and II patients aged 18-60 years undergoing orthopedic surgery under spinal anesthesia will be randomly allocated into two groups. The tramadol group will receive intravenous tramadol 0.5 mg\u002Fkg and the ketamine group will receive intravenous ketamine 0.25 mg\u002Fkg immediately after spinal anesthesia. Patients will be monitored for shivering, body temperature, vital signs, pain, nausea, vomiting, alertness, adverse effects, and rescue medication requirements for 90 minutes. Shivering will be assessed using a graded scale from 0 to 4.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Tramadol Group","ACTIVE_COMPARATOR","Participants in this group will receive intravenous tramadol 0.5 mg\u002Fkg immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.",[32],"Drug: Tramadol",{"label":34,"type":35,"description":36,"interventionNames":37},"Ketamine Group","EXPERIMENTAL","Participants in this group will receive intravenous ketamine 0.25 mg\u002Fkg immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.",[38],"Drug: Ketamin",[40,45],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":17},"DRUG","Tramadol","Intravenous tramadol 0.5 mg\u002Fkg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.",[28],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":17},"Ketamin","Intravenous ketamine 0.25 mg\u002Fkg will be administered immediately after spinal anesthesia for prevention of post-spinal anesthesia shivering.",[34],[50],{"name":51,"affiliation":52,"role":53},"Syed zafar Mehdi, Mbbs Fcps","Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT)","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":17,"email":59},"Aqsa Sattar, Mbbs Fcps 2( pg)","CONTACT","+92 342-2437774","aqsasattar920@gmail.com",[61],{"facility":52,"status":17,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Karachi","Sindh","74200","Pakistan","PK",{"type":68,"coordinates":69},"Point",[70,71],67.0104,24.8608,{"lat":71,"lon":70},[74,76],{"name":75,"role":57,"phone":58,"phoneExt":17,"email":59},"Aqsa Sattar, Mbbs Fcps ( pg)",{"name":77,"role":53,"phone":17,"phoneExt":17,"email":17},"Syed zafar Mehdi, Mbbs fcps",{"type":53,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Aqsa Sattar","Postgraduate traineee (Fcps ll candidate )","100653517","comparison-of-low-dose-intravenous-ketamine-and-tramadol-for-prevention-of-post-spinal-anaesthesia-shivering-in-orthopedic-surgical-patients-100653517",false,"NCT07787702","Comparison of Low-Dose Intravenous Ketamine and Tramadol for Prevention of Post-Spinal Anaesthesia Shivering in Orthopedic Surgical Patients","To Compare the Prophylactic Use of Low Doses of Intravenous Ketamine and Tramadol for the Prevention of Post Spinal Anaesthesia Shivering in Orthopedic Surgical Patients at Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT) Karachi, Sindh, Pakistan","Inclusion Criteria:\n\n* \\* ASA I and II patients aged 18-60 years.\n\n  * Both genders.\n  * Patients undergoing orthopedic surgery under spinal anesthesia.\n\nExclusion Criteria:\n\n* \\* Patient refusal.\n\n  * ASA III and ASA IV.\n  * Prolonged surgical procedures expected to be more than 90 minutes.\n  * Patients who received blood transfusion or study drugs other than for the study purpose.","ALL","18 Years","60 Years",{"count":92,"type":93},106,"ESTIMATED","INTERVENTIONAL",[96],"NA","This randomized controlled trial will compare the prophylactic effectiveness of low-dose intravenous ketamine and tramadol in preventing post-spinal anesthesia shivering in patients undergoing orthopedic surgery at Shaheed Mohtarma Benazir Bhutto Institute of Trauma (SMBBIT), Karachi,",[99],"Post-spinal Anesthesia Shivering","NOT_YET_RECRUITING","2026-08-22",{"date":103,"type":104},"2026-08-26","ACTUAL",{"date":106,"type":93},"2026-08-21",{"date":108,"type":93},"2027-02-21",{"name":5,"class":6},1]