Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex

NCT01965067 | Completed Phase 4 Results DMC

• 1 other identifier: MK8616-099
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary efficacy endpoint is the time from the start of administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition. Secondary endpoints include time from the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, vital signs \[heart rate and blood pressure\] at pre-reversal, post-reversal, recovery and post-anesthetic visit, the incidence of residual neuromuscular blockade, post-operative nausea and vomiting (PONV) and adverse events during mild hypothermia and the normal thermal condition. We hypothesize that mild hypothermia with core temperatures between 34.5°C and 35°C diminish the efficacy of sugammadex.

Conditions

Underdosing of Other General Anesthetics

Outcome Measures

Primary Outcomes (1)

• Reversal Time of Rocuronium

  The time from the administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition.

  The recovery time to the TOF ratio of 0.9 after the administration of the sugammadex, an expected average of 5 minutes

Secondary Outcomes (2)

• Mean Arterial Blood Pressure

  1 min before reversal, 1 min after reversal, 1 day after surgery

• Heart Rate

  1 min before reversal, 1 min after reversal, 1 day after surgery

Other Outcomes (3)

• Incidence of Residual Neuromuscular Blockade

  During 1day after operation

• Post-operative Nausea and Vomiting

  During 7days after operation

• Adverse Events

  During 7days after operation

Study Arms (2)

C group

ACTIVE COMPARATOR

normal thermal condition with core temperatures between 36.5°C and 37°C

Drug: sugammadex

H group

EXPERIMENTAL

mild hypothermia with core temperatures between 34.5°C and 35°C

Drug: sugammadex

Interventions

sugammadex DRUG

sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state Reversal effect of sugammadex in temperature state

C group; H group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient for elective abdominal surgery from 20 years (yrs) to 65 yrs Patient in American Society of Anesthesiologists criteria 1 or 2 Patient in the supine position with arm available for neuromuscular monitoring during operation

You may not qualify if:

• Patients expected to have a difficult airway, known neuromuscular disease, significant hepatic or renal dysfunction, family history of malignant hyperthermia, known allergy to one of the drugs used in this protocol, intake of any medication that might interact with muscle relaxants, pregnant, or breast feeding

Sponsors & Collaborators

• MSD Korea Ltd.: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Hanyang University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Lee HJ, Kim KS, Jeong JS, Kim KN, Lee BC. The influence of mild hypothermia on reversal of rocuronium-induced deep neuromuscular block with sugammadex. BMC Anesthesiol. 2015 Jan 21;15:7. doi: 10.1186/1471-2253-15-7.

  PMID: 25971394 DERIVED

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Kyo Sang Kim, MD, PhD
• Organization: Department of Anesthesiology and Pain Medicine, Hanyang University Hospital

kimks@hanyang.ac.kr

+82-2-2290-8680

Study Officials

• Kyo Sang Kim, MD, PhD

  Department of Anesthesiology and Pain Medicine, Hanyang University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 18, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

KR (1)