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IRCT20241106063628N1 IRCT 2024-11-15 National Medical Center Comparing Nalbuphine versus Tramadol to prevent Shivering after Lower limb surgery NTPS (Nalbuphine vs Tramadol for Post-Spinal Shivering) COMPARISON OF THE EFFECTIVENESS OF NALBUPHINE VERSUS TRAMADOL FOR PREVENTION OF POST SPINAL SHIVERING IN PATIENTS UNDERGOING LOWER LIMB SURGERY AT TERTIARY CARE HOSPITAL, KARACHI 2025-01-01 anticipated 60 Complete https://irct.ir/trial/80067 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method used is block Randomization in which using a technique of sealed opaque envelopes (SOE) to minimize selection bias, ensure comparable groups, and reduce confounding variables. Eligibility of participants are stratified by age, sex and surgery type, then randomly allocated to either Nalbuphine or Tramadol groups The randomization procedure are : 1.Assessing eligibility and obtaining informed consent 2.Stratifying participant 3.Using SOE for treatment assignment 4.Randomly allocating participants to treatment groups, Blinding description: - Sealed opaque envelopes bearing "N" (Nalbuphine) or "T" (Tramadol) are used for randomization. - Participants and outcome assessors are unaware of the treatment assignments. N/A Shivering. Intervention 1: Intervention group: Nalbuphine Group (NG)- Description: Patients receiving nalbuphine (0.5 mg/kg) intravenously over 5 minutes. Intervention 2: Intervention group: Tramadol Group (TG)- Description: Patients receiving tramadol (0.5 mg/kg) intravenously over 5 minutes. Yes - There is a plan to make this available What will be shared: "Nalbuphine-Tramadol Trial Dataset" Participant Data Sets: - Demographics (age, sex, weight, height) - Clinical outcomes (shivering assessment, vital signs, adverse events) - Intervention details (nalbuphine/tramadol dosage, administration time) - Follow-up data (post-operative shivering, pain scores). Specific IPD Shared: - All collected de-identified IPD for primary and secondary outcome measures - IPD collected for adverse events and serious adverse events Proforma: - Participant ID (anonymized) - Treatment group (nalbuphine/tramadol) - Shivering assessment (yes/no) - Vital signs (heart rate, blood pressure, temperature) - Adverse events (yes/no) When: 6 months after completion of study To whom: It will available for Institutional Review Board (IRB). College of Physician and Surgeon Pakistan (CPSP) . Conditions: Publication in peer-reviewed journals Education and training / Research purpose Presentation at Scientific conference Where to obtain: National Medical Center, Karachi. Study website (After Publication) Institutional review board (IRB) How to obtain: Study Principal Investigator/ Data Sharing Committee approves or rejects request. Requester is notify via email (approval/ Rejection) Comments:
public Prof.Brig.(R).Aneel Aslam
A-5/A, DHA Phase 1 Korangi Road, Karachi, Sindh - 75500
Karachi Pakistan 75500 +92 330 8431329 Akashdosani007@gmail.com National Medical Center scientific Muhammad Arslan Zahid
A-5/A, DHA Phase 1 Korangi Road, Karachi, Sindh - 75500
Karachi Pakistan 75500 +92 302 9205341 arslan.zahid@nmc.net.pk National medical center Pakistan Patients of either sex, between 20-60 years of age, receiving spinal anesthesia during lower limb surgery will be included in the study. ASA ≤ 2 20 years 60 years Both Patients undergoing emergency surgeries, deformities of the spine, hypersensitivity to any of the drugs in the study. Patients with thyroid or neuromuscular diseases. Patients on narcotics/sedatives. Patients allergic to nalbuphine or tramadol. Patients with an initial body (core) temperature >38.0°C or <36.0°C. Patients with h/o stroke, renal impairment, chronic obstructive pulmonary disease, asthma, chronic liver disease, and CCF will be excluded. R68.83 Chills (without fever) Prevention Prevention Intervention group: Nalbuphine Group (NG)- Description: Patients receiving nalbuphine (0.5 mg/kg) intravenously over 5 minutes Intervention group: Tramadol Group (TG)- Description: Patients receiving tramadol (0.5 mg/kg) intravenously over 5 minutes Shivering Assessment. Timepoint: initially at baseline (before intervention): immediately before administration Nalbuphine or Tramadol then, (post intervention): 15 minutes then 30 minutes, 1 hour then post surgery: 2hours. Method of measurement: Shivering assessment via grades 0 to 4: Grade 0: No shivering.• Grade 1: One or more of the following: Piloerection, peripheral vasoconstriction, peripheral cyanosis with, but without visible muscle activity.• Grade 2: Visible muscle activity confined to one muscle group.• Grade 3: Visible muscle activity in more than one muscle group.• Grade 4: Gross muscle activity involving the whole body. Shivering Assessment. Timepoint: initially at baseline (before intervention): immediately before administration Nalbuphine or Tramadol then, (post intervention): 15 minutes then 30 minutes, 1 hour then post surgery: 2hours. Method of measurement: shivering assessment via grades 0 to 4: Grade 0: No shivering.• Grade 1: One or more of the following: Piloerection, peripheral vasoconstriction, peripheral cyanosis with, but without visible muscle activity.• Grade 2: Visible muscle activity confined to one muscle group.• Grade 3: Visible muscle activity in more than one muscle group.• Grade 4: Gross muscle activity involving the whole body. National Medical Center Approved 2024-08-16 National Medical Center Ethical Research Committee (NMC-ERC) A-5/A, DHA Phase 1 Korangi Road, Karachi, Sindh - 75500 Karachi Sindh Pakistan