CClinicalTrials.gg
CompletedNCT02580188DEEPCOLUpdated Mar 13, 2019Results posted

The Effect of Deep Neuromuscular Block on Surgical Condition During Laparoscopic Colorectal Surgery

A Phase 4 interventional study of sugammadex in Neuromuscular Blockade, sponsored by Seoul National University Bundang Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by Seoul National University Bundang Hospital · Phase 4, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Mar 2015, registered Sep 2015).
Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Patients >18 years of age with an america society of anesthesiologist classification of I or II who were scheduled to undergo elective laparoscopic colorectal surgery were included. The exclusion criteria were a history of neuromuscular, renal, or hepatic disease, a history of low abdominal surgery; treatment with drugs known to interfere with neuromuscular function. Patients were randomised to either the moderate or deep neuromuscular blockade group using Random Allocation Software (version 1.0). Premedication with intravenous midazolam at 0.03 mg/kg was performed in the reception area. In the operating room, routine monitoring was performed, including electrocardiography, non-invasive arterial pressure measurements, and pulse oximetry. Additionally, acceleromyography was applied to monitor the response of the corrugator supercilii muscle. Neuromuscular management and monitoring were performed according to the Good Clinical Research Practice guidelines. After the induction of anaesthesia with propofol and remifentanil using target-controlled infusers and before rocuronium administration, the TOF-Watch-SX was calibrated and stabilised; a 50-Hz tetanic stimulation was applied for 5 s, the TOF-Watch-SX was calibrated, and a series of train-of-four (TOF) measurements were documented for >2 min until a stable baseline was obtained (\<5% variation in the TOF ratios). Next, intravenous rocuronium at 0.6 mg/kg was administered, and tracheal intubation was performed after confirmation of relaxation. Anesthesia was maintained with desflurane and target-controlled infusion of remifentanil while monitoring the bispectral index. A continuous dose of intravenous rocuronium (10-60 mg/hr) was used to maintain moderate (TOF count of 1 or 2) or deep (post-tetanic count [PTC] of 1 or 2) neuromuscular blockade. The IAP alarm(IAP>15mmHg) rate were checked. Any movement during the operation as reported by the surgeon or anaesthesiologist was recorded. At the end of the operation, the surgeon rated the surgical condition on a 5-point scale. Patients in the moderate group were reversed with neostigmine at 50 µg/kg and glycopyrrolate at 10 µg/kg at a TOF count of 1 or 2, and patients in the deep group were reversed with intravenous sugammadex at 4 mg/kg at PTC of 1 or 2. The time from administration of the reversal agents to a TOF ratio of 0.9 was recorded. Postoperative pain and opioid consumption were evaluated at 24, 48h postoperatively. Postoperative nausea and/or vomiting, dry mouth, were also evaluated at the same time points.

02

Conditions studied

  • Neuromuscular Blockade

Keywords

  • Neuromuscular blockade
  • Sugammadex
  • Laparoscopic surgery
  • Intra abdominal pressure alarm
03

In context

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • No intervention
    Moderate block

    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.

  • Experimental
    Deep block

    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

  • Drugsugammadex

    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

06

What researchers measure

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.

    Time frame: intraoperative, an averrage of 3 hour

Other outcomes

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

    Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.

    Time frame: 24hr after end of operation

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

    Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.

    Time frame: 48hr after end of operation

07

Results

Posted Aug 16, 2018

Participant flow

Participant flow — Overall Study
MilestoneGroup MGroup D
Started3535
Completed3232
Not completed33

Outcome measures

PrimaryNumber 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.

Time frame:
intraoperative, an averrage of 3 hour
Reported as:
Count of participants · Participants
Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg
ParticipantsModerate BlockDeep Block
Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg146
Other pre-specifiedPostoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)

Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.

Time frame:
24hr after end of operation
Reported as:
Median · score on a scale
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
score on a scaleModerate BlockDeep Block
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)4.5 (1 to 7)4 (0 to 8)
Other pre-specifiedPostoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)

Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.

Time frame:
48hr after end of operation
Reported as:
Median · score on a scale
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
score on a scaleModerate BlockDeep Block
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)3 (0 to 8)2 (0 to 7)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group M—0/35 (0%)0/35 (0%)
Group D—0/35 (0%)0/35 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group MGroup DTotal
<=18 years000
Between 18 and 65 years212445
>=65 years141125
Sex: Female, Male
Sex: Female, Male(Participants)Group MGroup DTotal
Female141529
Male212041
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02580188
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
BON WOOK KOO (assistant proffesor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Oct 20, 2015
Start date
Mar 24, 2015
Primary completion
Jun 16, 2016
Completion
Jun 18, 2016
Results posted
Aug 16, 2018
Last update
Mar 13, 2019

Study contacts

Ah-Young Oh, MD.,Ph.D.
study chair · Seoul national univ. BUNDANG hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion