Here is the design of a clinical trial:

Official Title: The NAPRESSIM Trial. The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.

Included conditions:
- Respiratory Depression

Study Armgroups:
- {'label': 'Naloxone', 'type': 'EXPERIMENTAL', 'description': 'The naloxone arm of the study will receive naloxone at a rate of 5mcg/kg/hr which equates to 0.25ml/kg/hr. Each 1 ml ampoule of solution contains 400 micrograms (0.4mg) naloxone hydrochloride present as naloxone hydrochloride dihydrate.\n\nExcipients: each 1ml contains 3.55mg sodium. This will be diluted to a concentration of 20mcg/ml with 0.9% NaCl. Presented as solution for injection or infusion. Clear colourless sterile solution.', 'interventionNames': ['Drug: Naloxone']}
- {'label': 'Saline', 'type': 'PLACEBO_COMPARATOR', 'description': 'The placebo arm of the study will receive an infusion of normal saline at a rate of 0.25ml/kg/hr.', 'interventionNames': ['Drug: Placebo']}

Interventions:
- {'type': 'DRUG', 'name': 'Naloxone', 'description': 'used to block the effects of opioids, especially in overdose', 'armGroupLabels': ['Naloxone']}
- {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo, ineffective control arm', 'armGroupLabels': ['Saline'], 'otherNames': ['Placebo Saline']}

Primary Outcomes:
- {'measure': 'Respiratory depression', 'timeFrame': 'within 16 - 24 hours of participation'}

Please estimate the sample size based on the assumption: 
To achieve a power of 80% at a 5% significance level, a one-tailed, two-proportion Z test with continuity correction was used. The initial sample size was 86, which was later inflated to account for a 10% dropout rate.
Sample size and power
        Sample size was estimated to determine the superiority of the prophylactic naloxone infusion compared to placebo in reducing the rate of respiratory depression. Based on an audit of 29 patient charts in our unit containing information on respiratory depression, the percentage of the target patient population who develop respiratory depression without treatment is estimated to be 31% (95% confidence interval (CI) 14.2â47.9%). This is based on the definition of respiratory depression in the ASA guidelines for prevention of respiratory depression with ITM [40].
        A clinically significant difference was defined as a 75% reduction in the percentage of respiratory depression among those on treatment, compared to those on placebo. Given the estimate of 31% for the placebo group, this is equivalent to a clinically significant relative risk of 4 (a four-times greater risk of respiratory depression for patients on placebo, than for those on treatment).
        Sample size calculations are based on a superiority hypothesis test of the risk of respiratory depression, formulated with the objective of testing whether the risk of respiratory depression is less for those on treatment than for those on placebo. To achieve a power of 80% for this test at a 5% significance level, a sample size of 43 per group is required or a total sample size of 86. This sample size calculation was calculated based on a one-tailed, two-proportion Z test with continuity correction.
        After commencement of the study the sample size was inflated to compensate for an un-anticipated dropout rate of up to 10%. The final sample size is 96 (48 per treatment group).