Deep Neuromuscular Block on Cytokines Release and Postoperative Delirium

NCT02507609 | Completed

• 1 other identifier: KUH1160087
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the relationship between the degree of neuromuscular block, the release of cytokines and clinical outcomes in elderly patients undergoing orthopedic surgery. Investigators hypothesize that deep neuromuscular blockade decreases the release of cytokine and the incidence of postoperative delirium in elderly patients undergoing orthopedic surgery, compared with moderate neuromuscular blockade.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Interleukin 6

  postoperative 4 hours

Secondary Outcomes (1)

• postoperative delirium

  up to postoperative day 7

Study Arms (2)

M group

ACTIVE COMPARATOR

moderate neuromuscular blockade group by intermittent injection of rocuronium bromide

Other: Moderate neuromuscular blockade

D group

ACTIVE COMPARATOR

deep neuromuscular blockade group by continuous infusion of rocuronium bromide

Other: Deep neuromuscular blockade

Interventions

Moderate neuromuscular blockade OTHER

TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation

Also known as: Esmeron

M group

Deep neuromuscular blockade OTHER

PTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route

Also known as: Esmeron

D group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult (more than 50 years old) patients scheduled for total hip arthroplasty and total knee arthroplasty who have signed the written informed consent.

You may not qualify if:

• Inability to give informed consent
• Preexisting cognitive dysfunction or delirium
• Known allergy to rocuronium sugammadex
• Underlying liver dysfunction (AST and ALT more than 100 IU/l)
• Underlying kidney dysfunction (Serum Creatinine more than 1.5 mg/dl)
• Underlying neuromuscular disease
• Patients taking any medication with potential interference with neuromuscular transmission

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

Related Publications (1)

• Oh CS, Lim HY, Jeon HJ, Kim TH, Park HJ, Piao L, Kim SH. Effect of deep neuromuscular blockade on serum cytokines and postoperative delirium in elderly patients undergoing total hip replacement: A prospective single-blind randomised controlled trial. Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S58-S66. doi: 10.1097/EJA.0000000000001414.

  PMID: 33399376 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Seong-Hyop Kim, M.D.

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 24, 2015
• Study Start: September 8, 2015
• Primary Completion: April 26, 2018
• Study Completion: April 26, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

KR (1)