Continuous Infusion and Bolus Doses of Rocuronium During Lumbal Discectomy, Muscle Strength and Patient Recovery

January 19, 2020 updated by: Martina Miklic Bublic, MD, PhD, Clinical Hospital Centre Zagreb

Comparison of the Effect of Continuous Infusion and Bolus Doses of Rocuronium During Anesthesia for Lumbal Discectomy on Muscle Strength and Quality of Patient Recovery

The continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rocuronium is a non-depolarising neuromuscular blocking agent that can be administered in bolus doses or via continuous infusion during general anesthesia. Due to the specificity of the knee-chest position in a lumbar discectomy, many complications during anesthesia and surgery are possible. Therefore an effective and balanced intraoperative neuromuscular block is needed.

Studies so far have not included a comparison on muscle strength and quality of patient recovery of the effect of continuous infusion and bolus doses of rocuronium during anesthesia for lumbar discectomy.

The hypothesis of this research was that the continuous infusion of rocuronium during general anesthesia for a lumbar discectomy enables better muscle strength recovery, and a better quality of patient recovery as measured by questionnaire.

The aim was to compare the influence of the continuous infusion and bolus doses of rocuronium on patient recovery. Therefore the investigators assessed how continuous infusion and bolus doses of rocuronium affect the recovery of muscle strength as measured by a hand-grip dynamometer. The quality of patient recovery was assessed by standardised questionnaire (Qor-40 - Quality of recovery questionnaire).

The aim was also to evaluate the applicability of the Croatian version of Qor-40 questionnaire in clinical practice.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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

  • Croatia
      • Zagreb, Croatia, 10000
        • UHCZagreb

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA ( American Society of Anesthesiologists) grading status I-III
  • scheduled for lumbal discectomy under general anesthesia
  • signed informed consent for participating in the research

Exclusion Criteria:

  • neuromuscular disease
  • poorly controlled chronic or acute cardiovascular, respiratory or autoimmune disease
  • allergic reaction to any of the medications in protocol
  • pregnancy
  • refusal to participate in the research

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rocuronium is administered via continuous infusion

40 patients. General anesthesia is maintained with propofol and remifentanil, with standard anesthetic monitoring, bispectral index (BIS) and train-of-four(TOF). In experimental group, rocuronium was administered via continuous infusion so that theTOF ratio was 5%. Hand-grip muscle strength was measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.

The quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery
Drug: Rocuronium
Rocuronium administered in continuous infusion or multiple bolus doses
Other Names:
  • general anesthesia
Active Comparator: rocuronium is administered in bolus doses

40 patients. General anesthesia was maintained with propofol and remifentanil, with standard anesthetic monitoring, BIS and TOF. In this group, rocuronium was administered in separate bolus doses with the TOF ratio of 5%.

Hand-grip muscle strength was measured with a dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.

The quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery
Drug: Rocuronium
Rocuronium administered in continuous infusion or multiple bolus doses
Other Names:
  • general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle strength
Time Frame: perioperative
Change in muscle strength between groups measured my hand-grip dynamometer on three occasions: before general anesthesia, in the early post-anesthesia period in the operating room, and 24 hours after anesthesia.
perioperative
Change in quality of patient recovery
Time Frame: up to 24 weeks

Change in quality of recovery between groups measured with Qor-40 questionnaire.

The quality of patient recovery was assessed with a Qor-40 questionnaire before anesthesia, 24 hours after anesthesia, and 30 days after anesthesia and surgery.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of Croatian version of the quality of recovery questionnaire (Qor-40)
Time Frame: perioperative
Translate to croatian language the quality of recovery questionnaire according to Beaton and Bullinger docrtine and evaluate the applicability of the Croatian version of Qor-40 questionnaire in clinical practice in croatian speaking area
perioperative

Collaborators and Investigators

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

Sponsor

Clinical Hospital Centre Zagreb

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.

General Publications

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 (Actual)

December 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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