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

Sponsor

Clinical Hospital Centre Zagreb (Other)

Overall Status

Completed

CT.gov ID

NCT04236050

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rocuronium Lumbar Discectomy Recovery	Drug: Rocuronium	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official 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

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in muscle strength [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.
Change in quality of patient recovery [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 Outcome Measures

Validation of Croatian version of the quality of recovery questionnaire (Qor-40) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UHCZagreb	Zagreb		Croatia	10000

Sponsors and Collaborators

Clinical Hospital Centre Zagreb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Martina Miklic Bublic, MD, PhD, Principal Investigator, Clinical Hospital Centre Zagreb

ClinicalTrials.gov Identifier:

NCT04236050

Other Study ID Numbers:

First Posted:

Jan 22, 2020

Last Update Posted:

Jan 22, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Martina Miklic Bublic, MD, PhD, Principal Investigator, Clinical Hospital Centre Zagreb

Additional relevant MeSH terms:

Rocuronium

Study Results

No Results Posted as of Jan 22, 2020