Rhabdomyolysis and Robot-assisted Radical Prostatectomy

January 31, 2016 updated by: Gulsah Karaoren, Umraniye Education and Research Hospital

Is Rhabdomyolysis an Anesthetic Complication in Patients Undergoing Robot-assisted Radical Prostatectomy?

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • gulsah Karaoren

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

patients scheduled for an elective Robot assisted radical prostatectomy were enrolled to the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Creatine Phosphokinase at 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
on the hours 0 (T9), 6 (T6), 12 (T12) and 24 (T24) after beginning of surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 31, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 31, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • GK9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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