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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02580188
Acronym
DEEPCOL
Enrollment
70
Registered
2015-10-20
Start date
2015-03-24
Completion date
2016-06-18
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular blockade, Sugammadex, Laparoscopic surgery, Intra abdominal pressure alarm

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.

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.

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).

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHgintraoperative, an averrage of 3 hourIntra-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.

Other

MeasureTime frameDescription
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)24hr after end of operationPostoperative 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.

Participant flow

Participants by arm

ArmCount
Group M
Maintenance dose of 0.15-0.3 mg/kg/hr rocuronium is 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.
35
Group D
Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is 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 sugammadex: Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium is continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
35
Total70

Baseline characteristics

CharacteristicGroup MGroup DTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
14 Participants11 Participants25 Participants
Age, Categorical
Between 18 and 65 years
21 Participants24 Participants45 Participants
Sex: Female, Male
Female
14 Participants15 Participants29 Participants
Sex: Female, Male
Male
21 Participants20 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 350 / 35
serious
Total, serious adverse events
0 / 350 / 35

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Moderate BlockNumber of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg14 Participants
Deep BlockNumber of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg6 Participants
Other Pre-specified

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

ArmMeasureValue (MEDIAN)
Moderate BlockPostoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)4.5 score on a scale
Deep BlockPostoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)4 score on a scale
Other Pre-specified

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

ArmMeasureValue (MEDIAN)
Moderate BlockPostoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)3 score on a scale
Deep BlockPostoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)2 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026