]>
IRCT20260807070565N1 IRCT 2026-09-13 Superior university Lahore Comparison of Dexmedetomidine and Tramadol as Adjuvants to Spinal Anesthesia in Femur Fracture Surgery The effect of dexmedetomidine versus tramadol as adjuvant in Spinal anesthesia in femur fracture surgery 2026-08-15 anticipated 68 Recruiting https://irct.ir/trial/92299 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Two-arm, parallel-group randomized controlled clinical trial comparing dexmedetomidine and tramadol as adjuvants to spinal anesthesia in patients undergoing femur fracture surgery, Randomization description: Eligible patients will be individually randomized in a 1:1 ratio into two groups: dexmedetomidine group and tramadol group. A computer-generated randomization sequence will be used to assign patients randomly to either group. Each patient will be assigned a study number and allocated according to the randomization sequence. No stratification or clustering will be used. N/A Femur fracture. Intervention group 1: Patients receiving intrathecal bupivacaine with dexmedetomidine as an adjuvant.Intervention group 2: Patients receiving intrathecal bupivacaine with tramadol as an adjuvant. No - There is not a plan to make this available Justification or reason for not sharing IPD is Deidentified individual participant data will not be shared because the data are collected for academic thesis purposes and are subject to participant confidentiality and institutional ethical requirements. Data will be accessible only to the research team and authorized supervisors/institutional authorities.
public Masaud shah
Muhalla lahorekheil dheri alladand,district malakand tehsil thana baizai
Malakand Pakistan 23020 +92 314 9822371 su91-msahw-f24-069@superior.edu.pk Superior university Lahore scientific Dr Usra Naeem
Raiwand road, kot arian, Lahore
Lahore Pakistan 54000 +92 333 4381978 usra.naeem@superior.edu.pk Superior university Lahore Pakistan patients aged 18-65 yeears both male and female patients ASA physical status I or II Undergoing elective femur fracture surgery under spinal anesthesia Willing to provide written inform consent 18 years 65 years Both contraindications to spinal anesthesia(coagulopathy,local infection,raised ICP) Known hypersensitivity to dexmedetomidine, tramadol or bupivacaine ASA physical status III or IV Significant cardiac, hepatic or renal impairment Chronic analgesic or opioid abuse S72 Fracture of femur Treatment - Drugs Intervention group 1: Patients receiving intrathecal bupivacaine with dexmedetomidine as an adjuvant.Intervention group 2: Patients receiving intrathecal bupivacaine with tramadol as an adjuvant Duration of postoperative analgesia. Timepoint: Measured from completion of spinal anesthesia until the first request for rescue analgesia (within the first 24 hours after surgery). Method of measurement: Measured in minutes from intrathecal drug administration to the first rescue analgesic requirement. Pain will be assessed using the Visual Analogue Scale (VAS), and rescue analgesia will be given when VAS ≥4. Hemodynamic stability (heart rate and mean arterial pressure). Timepoint: Baseline,5,10,15 and 30 minutes after spinal anesthesia. Method of measurement: Measured using a multi parameters monitoring and recorded as heart rate (beat/minute) and mean arterial pressure (mmHg). Superior university Lahore Approved 2024-08-24 Ethics committee of superior university Lahore Raiwand road,kot arian,Lahore Lahore Punjab Pakistan