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IRCT20231022059809N1 IRCT 2024-03-12 Combined Military Hospital Rawalpindi Comparison of forced air warming with warm intravenous fluid versus forced air warming alone in preventing hypothermia and shivering in obstetric patients None Comparison of forced air warming with warm intravenous fluid versus forced air warming alone in preventing hypothermia and shivering in obstetric patients 2023-05-22 anticipated 369 Complete https://irct.ir/trial/74016 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The method of randomization was non-probability consecutive via lottery method and patients were randomized into Group FWI (forced warming with warm IV fluid) and FWA (forced warming alone), Blinding description: Core temperature in both groups was recorded using a standard Braun Infrared Thermoscan5 thermometer (IRT 6500) by a resident anesthetist in the operating room unaware of the study protocol. N/A Prevention of hypothermia and shivering associated with spinal anesthesia for elective caesarian section.. Intervention 1: Intervention group: forced air warming with warm intravenous fluid in obstetric patients during Surgical procedures after Spinal Anaesthesia to prevent hypothermia. Intervention 2: Control group: forced air warming alone in obstetric patients during Surgical procedures after Spinal Anaesthesia to prevent hypothermia. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Shujaat Hussain
Saddar Rawapindi
Rawapindi Pakistan 00666 +92 343 4704199 Shujaat169@gmail.com Combined Military Hospital Rawalpindi scientific Saddam Hussain
Saddar Rawapindi
Rawapindi Pakistan 00666 0923434704199 Shujaat169@gmail.com CMH Rawapindi Pakistan Included all ASA-I and II Patients Female patients presenting for elective caesarian with a gestational age of 37 or more weeks under spinal anesthesia. no limit no limit Female Patients with pre-mature gestational age Caesarian converted to general anesthesia following spinal administration Patients with fever Cardiac or Respiratory disease Patients with PIH (pregnancy induced hypertension) or gestational diabetes mellites Patients unwilling to be included in the study T88.51 Hypothermia following anesthesia Prevention Prevention Intervention group: forced air warming with warm intravenous fluid in obstetric patients during Surgical procedures after Spinal Anaesthesia to prevent hypothermia Control group: forced air warming alone in obstetric patients during Surgical procedures after Spinal Anaesthesia to prevent hypothermia Core body temperature in both groups before procedure, per-operatively and post-operatively. Timepoint: Core body temperature in both groups’ pre-spinal, 30 and 60 minutes into the procedure and then at 30- and 60-minute intervals in the PACU post-procedure. Method of measurement: Core temperature in both groups was recorded using a standard Braun Infrared Thermoscan5 thermometer (IRT 6500) by a resident anesthetist in the operating room unaware of the study protocol. Incidence of Shivering due to hypothermia Per-operative and post-operatively in recovery room. Timepoint: Shivering in both groups’ 30 and 60 minutes into the procedure after spinal and then at 30- and 60-minute intervals in the PACU post-procedure. Method of measurement: Clinical and visual assessment of Shivering alongwith measurement of core body temperature by using standard Braun Infrared Thermoscan5 thermometer (IRT 6500). Combined Military Hospital Rawalpindi Approved 2023-05-20 Ethical Committee Of Combined Military Hospital Rawalpindi Saddar Rawalpindi Rawalpindi Punjab Pakistan