Skip to main content
OpenTrials
Completed

NCT Number: NCT04236050

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHCZagreb

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

Rocuronium administered in continuous infusion or multiple bolus doses

Other names: general anesthesia

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Clinical Hospital Centre Zagreb

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 22, 2020
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.