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Rhabdomyolysis and Robot-assisted Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671604
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Gulsah Karaoren, Umraniye Education and Research Hospital

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
Rhabdomyolysis

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 52 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Is Rhabdomyolysis an Anesthetic Complication in Patients Undergoing Robot-assisted Radical Prostatectomy?
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015



Primary Outcome Measures :
  1. Number of Participants With serumCreatine Phosphokinase Values greater than 5000IU/L [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients scheduled for an elective Robot assisted radical prostatectomy were enrolled to the study.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671604


Locations
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Turkey
gulsah Karaoren
Istanbul, Turkey
Sponsors and Collaborators
Umraniye Education and Research Hospital
Investigators
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Study Director: eyup v kucuk, md Umraniye Education and Research Hospital
Additional Information:

Publications of Results:
Other Publications:
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Responsible Party: Gulsah Karaoren, MD, Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02671604    
Other Study ID Numbers: GK9
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gulsah Karaoren, Umraniye Education and Research Hospital:
acute renal failure
prostatectomy
minimal invasive surgery
Additional relevant MeSH terms:
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Rhabdomyolysis
Muscular Diseases
Musculoskeletal Diseases