Only first 10,000 results will be saved in the file.
No item is selected. Use checkboxes to select search results.
Displaying 1-1 of 1 results.
{{ selectedCountPage }} items selected on this page,{{ selectedCountPage }} item selected on this page,{{ selectedCountTotal }} item in total{{ selectedCountTotal }} items in total
Study aim:
Determination of the effect of rectal diclofenac suppository prophylaxis on shivering after cesarean section
Design:
Study Design:
Double-blind randomized controlled trial
Two parallel groups (intervention vs placebo)
Single-center study
Sample Size:
100 total participants (50 per group)
Calculated based on:
Type I error (α) = 0.05
Power = 80%
Expected minimum difference of 25% in post-anesthesia shivering between groups
Randomization:
Simple randomization method
Individual-level randomization (not cluster)
Computer-generated random numbers
Double-blinding implemented (both patients and post-operative observers are blinded to group allocation)
Study Groups:
Intervention Group:
Receives 100mg rectal diclofenac suppository 10 minutes before surgery
Standard anesthesia protocol
Control Group:
Receives placebo suppository 10 minutes before surgery
Same standard anesthesia protocol
Settings and conduct:
This double-blind randomized controlled trial will be conducted at a single center. The study will involve women aged 18-40 years undergoing cesarean section with ASA status I or II. The operating room temperature will be maintained at 22-24°C throughout the procedures.
Participants/Inclusion and exclusion criteria:
Inclusion Criteria:
Women aged 18-40 years
Undergoing cesarean section
ASA status I or II
Willing to participate in the study
Exclusion Criteria:
Allergy to diclofenac
Cardiovascular disease
Hypertension
Diabetes
Kidney disease
Chronic lung disease
Liver disease
History of alcohol consumption
Body temperature below 36°C
Body temperature above 38°C
Intervention groups:
Receives 100mg rectal diclofenac suppository 10 minutes before surgery
Main outcome variables:
Determination of the effect of rectal diclofenac suppository prophylaxis on shivering after cesarean section