Perioperative Muscle Relaxant and Postoperative Outcomes

NCT ID: NCT04371588

Last Updated: 2022-09-02

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

COMPLETED

Total Enrollment

999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-17

Study Completion Date

2021-08-12

Brief Summary

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Muscle relaxant is usually needed for surgery. However, the optimal depth of neuro-muscular blockade is still on debate. Deep neuro-muscular blockade may benefit the patients during surgery, but may increase the risk of residual blockade after surgery. Residual blockade has been reported to increase risk of morbidity. In this study, we tend to observe the postoperative outcomes in patients undergoing abdominal surgery under general anesthesia. And to compare the outcomes in patients received different depth of neuro-muscular blockade.

Detailed Description

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Conditions

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Postoperative Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Deep neuro-muscular blockade

No Response to Train of Four Stimulation

Intervention Type OTHER

No response is observed during Train of Four stimulation monitoring during surgery

Moderate neuro-muscular blockade

1-2 Response to Train of Four Stimulation

Intervention Type OTHER

1 to 2 response is observed during Train of Four stimulation monitoring during surgery

Interventions

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No Response to Train of Four Stimulation

No response is observed during Train of Four stimulation monitoring during surgery

Intervention Type OTHER

1-2 Response to Train of Four Stimulation

1 to 2 response is observed during Train of Four stimulation monitoring during surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years old
* Body mass \<18 kg/m2
* American Society of Anesthesiologists status I-II
* Patients scheduled for elective laparoscopic colorectal or urological surgery
* Patients received general anesthesia and muscle relaxant
* Patients with written informed consent.

Exclusion Criteria

* Second surgery during the same admission.
* Outpatient surgery
* Retroperitoneal laparoscopic surgery
* Patients scheduled for mechanical ventilation after surgery
* Patients scheduled for muscle relaxant other than rocuronium
* Patients with pregnancy or planned for breeding
* Patients who are involved in other studies
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 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

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First hospital of Beijing University

Beijing, Beijing Municipality, China

Site Status

Xiehe Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status

First Afiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Tongji Hospital of Tongji Medical School

Wuhan, Hubei, China

Site Status

Xiehe Hospital of Tongji Medical School

Wuhan, Hubei, China

Site Status

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Huaxi Hospital

Chengdu, Sichuan, China

Site Status

General hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status

People's Hospital of Jiangsu

Nanjing, , China

Site Status

Countries

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China

References

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Madsen MV, Istre O, Staehr-Rye AK, Springborg HH, Rosenberg J, Lund J, Gatke MR. Postoperative shoulder pain after laparoscopic hysterectomy with deep neuromuscular blockade and low-pressure pneumoperitoneum: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):341-7. doi: 10.1097/EJA.0000000000000360.

Reference Type BACKGROUND
PMID: 26479510 (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-20290110

Identifier Type: -

Identifier Source: org_study_id

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