NCT02580188

Brief Summary

This study is a randomized, controlled, double-blinded, and parallel design study. A total 96 patients were randomized to receive a deep block or a moderate block scheduled for elective laparoscopic colorectal surgery. Investigators estimated the proportion of intra-abdominal pressure(IAP) alarm and surgical rating score.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2016

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 16, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

September 30, 2015

Results QC Date

January 28, 2018

Last Update Submit

March 12, 2019

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular blockadeSugammadexLaparoscopic surgeryIntra abdominal pressure alarm

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg

    Intra-abdominal pressure was maintained at 12 mmHg during pneumoperitoneum(using the carbon dioxide gas insufflation) and the pressure alarm for IAP was set at \< 15 mmHg. Intra-abdominal pressure is measured in a separate machine connected to a carbon dioxide gas injection line.

    intraoperative, an averrage of 3 hour

Other Outcomes (2)

  • Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)

    24hr after end of operation

  • Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)

    48hr after end of operation

Study Arms (2)

Moderate block

NO INTERVENTION

Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.

Deep block

EXPERIMENTAL

Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block

Drug: sugammadex

Interventions

sugammadexDRUG

Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).

Also known as: deep block
Deep block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists grade 1 or 2
  • Scheduled for elective laparoscopic Colorectal surgery

You may not qualify if:

  • Severe respiratory or cardiac disease
  • Severe hepatic or renal function impairment
  • On medications affecting neuromuscular function
  • Known allergy to the drugs to be used
  • Pregnant
  • Malignant hyperthernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Dr. Bon-wook Koo
Organization
SNUBH
tendong2@gmail.com
+82-10-7227-1379

Study Officials

  • Ah-Young Oh, MD.,Ph.D.

    Seoul national univ. BUNDANG hospital

    STUDY CHAIR

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
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant proffesor

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 20, 2015

Study Start

March 24, 2015

Primary Completion

June 16, 2016

Study Completion

June 18, 2016

Last Updated

March 13, 2019

Results First Posted

August 16, 2018

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share