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

NCT04236050 | Completed

• 1 other identifier: 021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Rocuronium; Lumbar Discectomy; Recovery

Keywords

rocuronium; Qor-40; lumbar discectomy; muscle strength

Outcome Measures

Primary Outcomes (2)

• Change in muscle strength

  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

  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 Outcomes (1)

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

  perioperative

Study Arms (2)

rocuronium is administered via continuous infusion

EXPERIMENTAL

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 is administered in bolus doses

ACTIVE COMPARATOR

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

Interventions

Rocuronium DRUG

Rocuronium administered in continuous infusion or multiple bolus doses

Also known as: general anesthesia

rocuronium is administered in bolus doses; rocuronium is administered via continuous infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

UHCZagreb

Zagreb, 10000, Croatia

Location

Related Publications (9)

• Fuchs-Buder T, Schmartz D. [Residual neuromuscular blockade]. Anaesthesist. 2017 Jun;66(6):465-476. doi: 10.1007/s00101-017-0325-1. German.

  PMID: 28573344 RESULT

• Naguib M, Flood P, McArdle JJ, Brenner HR. Advances in neurobiology of the neuromuscular junction: implications for the anesthesiologist. Anesthesiology. 2002 Jan;96(1):202-31. doi: 10.1097/00000542-200201000-00035. No abstract available.

  PMID: 11753022 RESULT

• Srivastava A, Hunter JM. Reversal of neuromuscular block. Br J Anaesth. 2009 Jul;103(1):115-29. doi: 10.1093/bja/aep093. Epub 2009 May 24.

  PMID: 19468024 RESULT

• Jellish WS, Brody M, Sawicki K, Slogoff S. Recovery from neuromuscular blockade after either bolus and prolonged infusions of cisatracurium or rocuronium using either isoflurane or propofol-based anesthetics. Anesth Analg. 2000 Nov;91(5):1250-5. doi: 10.1097/00000539-200011000-00037.

  PMID: 11049917 RESULT

• Sweeney BP. Neuromuscular blockade and minimal monitoring. Anaesthesia. 2010 Mar;65(3):308. doi: 10.1111/j.1365-2044.2010.06252.x. No abstract available.

  PMID: 20236270 RESULT

• Gatke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Postoperative muscle paralysis after rocuronium: less residual block when acceleromyography is used. Acta Anaesthesiol Scand. 2002 Feb;46(2):207-13. doi: 10.1034/j.1399-6576.2002.460216.x.

  PMID: 11942873 RESULT

• Desai A, Bekelis K, Ball PA, Lurie J, Mirza SK, Tosteson TD, Zhao W, Weinstein JN. Spine patient outcomes research trial: do outcomes vary across centers for surgery for lumbar disc herniation? Neurosurgery. 2012 Oct;71(4):833-42. doi: 10.1227/NEU.0b013e31826772cb.

  PMID: 22791040 RESULT

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 RESULT

• Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. doi: 10.1097/00000542-200311000-00024.

  PMID: 14576554 RESULT

MeSH Terms

Interventions

Rocuronium; Anesthesia, General

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 22, 2020
• Study Start: December 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

CR (1)