Shivering
Conditions
Keywords
Shivering, Spinal Anesthesia
Brief summary
The goal of this clinical trial is to compare the effectiveness of tramadol versus ketamine in preventing shivering after spinal anesthesia in adult patients (ages 20-65) undergoing elective lower abdominal or inguinoscrotal surgeries. The main questions it aims to answer are: * Does prophylactic intravenous tramadol reduce the incidence and severity of shivering more effectively than ketamine after spinal anesthesia? * Are there differences in side effects, such as sedation or nausea, between tramadol and ketamine? Researchers will compare the tramadol group to the ketamine group to see which drug is more effective and safer for shivering prevention. Participants will: * Be randomly assigned to receive either tramadol (1 mg/kg) or ketamine (0.5 mg/kg) five minutes after spinal anesthesia. * Have their shivering severity assessed at 15, 30, 45, and 60 minutes using a standardized scale. * Be monitored for sedation, nausea, and other possible side effects.
Interventions
DRUGTramadol
Tramadol 1 mg/kg IV given 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering
DRUGKetamine
Ketamine 0.5 mg/kg IV administered 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering.
Sponsors
Syed Muhammad Abbas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The study medications were prepared in identical syringes by an independent anesthesiologist not involved in patient care to maintain blinding. Both the anesthesia providers and outcome assessors were blinded to group allocation throughout the study.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients aged 20 to 65 years, 2. American Society of Anesthesiologists (ASA) Physical Status I or II, and 3. Scheduled for elective lower abdominal or inguinoscrotal surgeries 4. Under spinal anesthesia were included
Exclusion criteria
1. Thyroid or neuromuscular disorders, 2. Pregnant 3. History of chronic sedative or narcotic use, 4. Requiring intraoperative blood transfusion 5. Had a baseline body temperature greater than 38°C or less than 36°C, 6. Undergoing transurethral resection of the prostate (TURP).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Post-Spinal Anesthesia Shivering | Up to 60 minutes post spinal anesthesia | The incidence and severity of shivering will be assessed using the Bedside Shivering Assessment Scale (BSAS) at 15, 30, 45, and 60 minutes following the administration of spinal anesthesia. BSAS Grading: * 0 = No shivering * 1 = Piloerection or peripheral vasoconstriction without visible shivering * 2 = Visible muscular activity confined to one muscle group * 3 = Gross muscular activity involving the entire body |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation Score | Up to 60 minutes post spinal anesthesia | Sedation will be measured using the Ramsay Sedation Scale (RSS) at 15, 30, 45, and 60 minutes post spinal anesthesia. RSS scores range from 1 (anxious, agitated) to 6 (no response). Median and interquartile ranges will be calculated for each group. |
| Incidence of Postoperative Nausea and Vomiting (PONV) | Up to 60 minutes post spinal anesthesia | PONV will be assessed using the PONV Impact Scale at 15, 30, 45, and 60 minutes post spinal anesthesia. Presence or absence will be recorded at each time point. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rescue Analgesic Use | Within 60 minutes post spinal anesthesia | Administration of rescue pethidine (0.35 mg/kg IV) for Grade 3 shivering lasting more than 15 minutes will be recorded. |
| Adverse Events Monitoring | Intraoperative and up to 60 minutes post spinal anesthesia | Incidence of other side effects including hypotension, hypertension, hallucinations, and excessive sedation will be actively monitored and recorded intraoperatively and up to 60 minutes after spinal anesthesia. |
Countries
Pakistan
Outcome results
None listed