Muscle Relax Affects Outcomes of Robotic Surgery

NCT ID: NCT03726372

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-10

Study Completion Date

2019-11-10

Brief Summary

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During robotic laparoscopic surgery, a high intraperitoneal pressure may result in high airway pressure and inadequate perfusion of the abdominal organs, and as a result the postoperative outcomes. Degree of neuromuscular blockade (NMB) can affect the intraperitoneal pressure. In this study, the patients undergoing robotic laparoscopic surgery will be assigned to deep NMB group and moderate NMB group. Perioperative outcomes including maximal intraperitoneal pressure, maximal intraoptic pressure, quality of emergence, postoperative pain, and incidence of postoperative respiratory complication will be compared. The results of this study will provide evidence for optimizing NMB protocol of robotic laparoscopic surgery.

Detailed Description

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Conditions

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General Anesthesia Postoperative Complications

Keywords

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robotic surgery laparoscopic surgery neuromuscular blockade postoperative complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Muscle relaxant will be given by a specific investigator that is not involved in anesthesia and outcome assessment

Study Groups

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deep neuromuscular blockade

Rocuronium, a neuromuscular blocking agent will be given by continuous infusion at a dose that reaction to train of four (TOF) stimulation is depressed to zero

Group Type EXPERIMENTAL

Rocuronium

Intervention Type DRUG

rocuronium is a neuromuscular blocking agent with a duration of 40 minutes

continuous infusion

Intervention Type OTHER

rocuronium is continuously infused

moderate neuromuscular blockade

Rocuronium, a neuromuscular blocking agent will be given at a dose by intermittent injection that reaction to train of four (TOF) stimulation is kept 1 to 2

Group Type EXPERIMENTAL

Rocuronium

Intervention Type DRUG

rocuronium is a neuromuscular blocking agent with a duration of 40 minutes

intermittent injection

Intervention Type OTHER

rocuronium is intermittently given

Interventions

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Rocuronium

rocuronium is a neuromuscular blocking agent with a duration of 40 minutes

Intervention Type DRUG

continuous infusion

rocuronium is continuously infused

Intervention Type OTHER

intermittent injection

rocuronium is intermittently given

Intervention Type OTHER

Other Intervention Names

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rocuronium bromide high dose low dose

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for elective robotic laparoscopic surgery under general anesthesia
* American Society of Anesthesiologists status 1-2
* Body mass index of 18-30kg/m2
* Patients scheduled to be positioned in trendelenburg position during surgery

Exclusion Criteria

* Patients allergic to rocuronium
* Patients with neuromuscular dysfunction
* Patients with existed pulmonary diseases
* Patients with hepatic or renal dysfunction
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhihong Lu

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Central Contacts

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Zhihong Lu

Role: CONTACT

Phone: 86-13891975018

Email: [email protected]

Hailong Dong

Role: CONTACT

Phone: 86-84775337

Email: [email protected]

References

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Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13.

Reference Type BACKGROUND
PMID: 25684372 (View on PubMed)

Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

Reference Type BACKGROUND
PMID: 24240315 (View on PubMed)

Barrio J, Errando CL, Garcia-Ramon J, Selles R, San Miguel G, Gallego J. Influence of depth of neuromuscular blockade on surgical conditions during low-pressure pneumoperitoneum laparoscopic cholecystectomy: A randomized blinded study. J Clin Anesth. 2017 Nov;42:26-30. doi: 10.1016/j.jclinane.2017.08.005. Epub 2017 Aug 30.

Reference Type BACKGROUND
PMID: 28803124 (View on PubMed)

Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.

Reference Type BACKGROUND
PMID: 27936214 (View on PubMed)

Other Identifiers

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XJH-A-20180701

Identifier Type: -

Identifier Source: org_study_id