Patients undergoing Transurethral Resection of the Prostate (TURP) under spinal anesthesia TURP Shivering Paracetamol Acetaminophen Spinal anesthesia
Conditions
Interventions
An anesthesiologist not involved in patient care prepared the study drug. The drug will be transferred from its original vial, prepared, and labeled with the patient'
s identification number under sterile conditions. The study solution contained 1,000 mg of paracetamol in a 100 mL volume, administered intravenously over a 15-minute drip starting after lithotomy pos
Experimental Drug,Placebo Comparator Drug
1,000 mg of paracetamol,100 mL of normal saline
Sponsors
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age > 40 years. (Patients older than 60 years will undergo cognitive function assessment using the Mini-Cog test. Participants without cognitive impairment will provide consent themselves. If cognitive impairment is present, consent will be obtained from a first-degree relative.) 2. ASA Physical status I - III 3. Undergoing Transurethral Resection of the Prostate (TURP) Under Spinal Anesthesia
Exclusion criteria
Exclusion criteria: 1. Decline to provide consent to participate in a study 2. Patient with contraindications for spinal anesthesia 3. All participants that have history of paracetamol allergy and its substance allergy 4. Participants who are at risk for taking paracetamol including severe liver cirrhosis, alcohol abuse, or malnutrition 5. End stage renal disease (ESRD) 6. Severe COPD 7. Body weight less than 50 kilogram 8. Body temperature greater than 37.8 C or less than 36 C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of shivering every 10 minutes after spinal anesthesia until the surgery is completed, and then at 0, 15, 30, 45, and 60 minutes in the recovery room. A bedside shivering assessment score of one or more | — |
Secondary
| Measure | Time frame |
|---|---|
| body temperature and vital signs before and after spinal anesthesia every 10 minutes until the surgery is completed, and then at 0, 15, 30, 45, and 60 minutes in the recovery room. Blood pressure, heart rate, body temperature, oxygen saturation,The bedside shivering assessment score after spinal anesthesia every 10 minutes until the surgery is completed, followed by recordings at 0, 15, 30, 45, and 60 minutes in the recovery room. 0 is no shivering, 1 is piloerection or vasoconstriction without visible shivering, 2 is one muscle group, 3 is multiple groups, and 4 is whole-body shivering.,Pain scores 0, 15, 30, 45, and 60 minutes in the recovery room Numeric Rating Scale,Total opioid consumption from the time after spinal anesthesia up to 24 hours postoperatively. morphine equivalent (mg),complications from the time after spinal anesthesia up to 24 hours postoperatively. such as hypotension, nausea, or vomiting | — |
Countries
Thailand
Contacts
Public ContactSasima Dusitkasem
Department of Anesthesiology Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed