Rhabdomyolysis and Robot-assisted Radical Prostatectomy

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2016
• Main ID: NCT02671604
• Date of registration: 21/01/2016
• Prospective Registration: No
• Primary sponsor: Umraniye Education and Research Hospital
• Public title: Rhabdomyolysis and Robot-assisted Radical Prostatectomy
• Scientific title: Is Rhabdomyolysis an Anesthetic Complication in Patients Undergoing Robot-assisted Radical Prostatectomy?
• Date of first enrolment: January 2014
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02671604
• Study type: Observational [Patient Registry]
• Study design: Observational Model: Case Control, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Turkey

Contacts

• Name: eyup v kucuk, md
• Affiliation: Umraniye Education and Research Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- ASA I-II

- Aged 50-80 years,

- BMI >25 kg/m2

- Patients scheduled for an elective RARP

Exclusion Criteria:

- Patients with ASA III-IV risk status,

- Patients with comorbid diseases that can cause increased muscular activity such as
severe dystonia or status asthmaticus,

- Patients with renal or hepatic failure and patients on statin or steroid therapy were
excluded.

- Patients converted to laparotomy during surgery.



Age minimum: 50 Years
Age maximum: 80 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Rhabdomyolysis

Primary Outcome(s)

Number of Participants With serumCreatine Phosphokinase Values greater than 5000IU/L [Time Frame: Change from Baseline Creatine Phosphokinase at 24 hours.]

Secondary Outcome(s)

number of patients with abnormal laboratory values [Time Frame: on the hours 0 (T9), 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery.]

Secondary ID(s)

GK9

Source(s) of Monetary Support

Please refer to primary and secondary sponsors