The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

NCT ID: NCT02109133

Last Updated: 2015-06-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-12-31

Brief Summary

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Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.

Detailed Description

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Conditions

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Robot-Assisted Laparoscopic Radical Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Deep neuromuscular blockade

Deep neuromuscular blockade

Group Type EXPERIMENTAL

deep neuromuscular blockade

Intervention Type PROCEDURE

deep neuromuscular blockade using rocuronium and reverse with sugammadex

Rocuronium

Intervention Type DRUG

Sugammadex

Intervention Type DRUG

moderate neuromuscular blockade

moderate neuromuscular blockade

Group Type ACTIVE_COMPARATOR

moderate neuromuscular blockade

Intervention Type PROCEDURE

moderate neuromuscular blockade using atracurium and reverse with neostigmine

Atracurium

Intervention Type DRUG

Neostigmine

Intervention Type DRUG

Interventions

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deep neuromuscular blockade

deep neuromuscular blockade using rocuronium and reverse with sugammadex

Intervention Type PROCEDURE

moderate neuromuscular blockade

moderate neuromuscular blockade using atracurium and reverse with neostigmine

Intervention Type PROCEDURE

Rocuronium

Intervention Type DRUG

Sugammadex

Intervention Type DRUG

Atracurium

Intervention Type DRUG

Neostigmine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. ASA class I-II
2. obtaining written informed consent from the parents
3. aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy

Exclusion Criteria

1. eye surgery previously
2. unstable angina or congestive heart failure
3. concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment)
4. high intraocular pressure over 30mmHg after screening test.
5. uncontrolled hypertension (diastolic bp\>110mmHg)
6. coagulopathy
7. asthma
8. hepatic failure
9. renal failure(creatinine clearance \< 30 ml/min)
10. drug hyperactivity
11. neurological or psychiatric illnesses
12. mental retardation
13. patients who can't read the consent form due to illiterate or foreigner
14. previous malignant hyperthermia Hx
15. drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc)
16. BMI \> 30kg/m2
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park H, Bai SJ. The Intraocular Pressure under Deep versus Moderate Neuromuscular Blockade during Low-Pressure Robot Assisted Laparoscopic Radical Prostatectomy in a Randomized Trial. PLoS One. 2015 Aug 28;10(8):e0135412. doi: 10.1371/journal.pone.0135412. eCollection 2015.

Reference Type DERIVED
PMID: 26317357 (View on PubMed)

Other Identifiers

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4-2014-0058

Identifier Type: -

Identifier Source: org_study_id

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