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Rhabdomyolysis and Robot-assisted Radical Prostatectomy

Sponsor
Umraniye Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02671604
Collaborator
(none)
52
Enrollment
1
Location
12
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In patients undergoing robot-assisted radical prostatectomy (RARP), pneumoperitoneum, intraoperative fluid restriction and prolonged Trendelenburg position may cause rhabdomyolysis (RM) due to hypoperfusion in gluteal muscles and lower extremities.

In this study, it was aimed to assess effects of BMI, comorbidities, intraoperative positioning, fluid restriction and length of surgery on development of RM in RARP patients during perioperative period.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Fifty-two ASA I-II patients aged 50-80 years, BMI >25 kg/m2 scheduled for an elective RARP were enrolled to the study.

    In all patients, pre-anesthetic evaluations including laboratory tests and Charlson Comorbidity Index (CCI) were performed one week before surgery in anesthesia clinic. Comorbid diseases were rated based on CCI. A 4-points scale was used to rate comorbid conditions [1 mild; 4 severe]. Comorbidity grading was performed by adding scores given for each comorbid disease. Based on the grading, patients were stratified into 4 groups as follows: grade 0, 1-2, 3-4 and ≥ 5

    In the operation room, intubation was performed after standard anesthesia For surgery, patients were placed in low lithotomy position. All patients were placed on a soft sponge mattress and soft padding gel pads were provided above the shoulders. The patients were placed in a 30-degree STP after achieving pneumoperitoneum at an intra-abdominal pressure level of 15 mmHg. After placing patient to desired position (T0), blood samples were drawn for measurements of ABG, Na, Cl, Ca, K, BUN, Cr, AST, ALT, LDH, cTp-I, CK-MB and CPK.

    During the operation, normal saline (1 m/kg/hr) and 6% HES 200/05 (1 ml/kg/hr) infusions were applied. Operation time (OT) and Trendelenburg time (TT) were recorded in all patients.

    Blood samples were repeated on the hours 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery. Hydration with 2000 ml crystalloid solution was given until hour 24 after surgery. In all patients, urine output was monitored.

    Rhabdomyolysis was defined as postoperative serum CPK level exceeding 5,000 IU/L. It was planned to manage these patients with hypervolemic therapy, correction of acidosis by using IV sodium bicarbonate and stimulation of diuresis by IV furosemide with a goal of maintaining minimal diuresis of 60 ml/hr at pH level of 7.

    Postoperative RF was defined as an increase in serum creatinine of 1mg/dl/day (or 90 mmol/l/day) for 2 consecutive days beyond the baseline.

    Patients were discharged with control laboratory tests, including the same parameters, on the hour 48 (T48) postoperatively.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    52 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Is Rhabdomyolysis an Anesthetic Complication in Patients Undergoing Robot-assisted Radical Prostatectomy?
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    Jan 1, 2015
    Actual Study Completion Date :
    Jan 1, 2015

    Outcome Measures

    Primary Outcome Measures

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

      Rhabdomyolysis was defined as postoperative serum Creatine Phosphokinase level exceeding 5000 IU/L.

    Secondary Outcome Measures

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

      Laboratory values of serum Na, Cl, Ca, K, BUN, Cr, AST, ALT, LDH, cTp-I, CK-MB

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 gulsah Karaoren Istanbul Turkey

    Sponsors and Collaborators

    • Umraniye Education and Research Hospital

    Investigators

    • Study Director: eyup v kucuk, md, Umraniye Education and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gulsah Karaoren, MD, Umraniye Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT02671604
    Other Study ID Numbers:
    • GK9
    First Posted:
    Feb 2, 2016
    Last Update Posted:
    Feb 2, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Gulsah Karaoren, MD, Umraniye Education and Research Hospital
    acute renal failure
    prostatectomy
    minimal invasive surgery
    Additional relevant MeSH terms:
    Rhabdomyolysis

    Study Results

    No Results Posted as of Feb 2, 2016