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Compare of Surgical Condition and Complications With Moderate and Deep NM Block (MISPCNUHH)

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ClinicalTrials.gov Identifier: NCT02601508
Recruitment Status : Unknown
Verified November 2015 by Seongwook Jeong, Chonnam National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 10, 2015
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Seongwook Jeong, Chonnam National University Hospital

Brief Summary:
This study is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.The explorative objective of this study is to evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of postoperative complications.

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Rocuronium Drug: cis-atracurium Not Applicable

Detailed Description:
Neuromuscular blocking agents (NMBAs) are frequently using during anesthesia to facilitate tracheal intubation and to improve surgical conditions. In an adequately anesthetized and monitored patient, the presence of one or two responses in the train-of-four (TOF) pattern normally indicates sufficient relaxation for most surgical procedures in general practices. It has been called moderate neuromuscular blockade (mNMB) condition. Nowadays, laparoscopic surgeries have expanded impressively into various areas of surgeries, both in scope and volume. If any hypothetical advantages of deep neuromuscular blockade (dNMB) during laparoscopic surgery turned out to be realized in practice with sufficient supporting evidence, it would become an important anesthetic option for better patient outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel Design, Single-center Study to Compare of Surgical Condition and Postoperative Complications With Moderate and Deep Neuromuscular Blockade in Laparoscopic Gastrectomy
Study Start Date : November 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Active Comparator: Modarate Blockade Group
Neuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine & glycopyrrolate will be given for the recovery.
Drug: cis-atracurium
Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine & Glycopyrrolate
Other Name: Nimbex®

Experimental: Deep Blockade Group
Neuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery.
Drug: Rocuronium
Continuous infusion of rocuronium for PTC 1 + Sugammadex
Other Name: Esmeron®




Primary Outcome Measures :
  1. Surgical rating SCORE(SRS) [ Time Frame: every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery ]
    excellent (5), good but not optimal (4), moderate (3), poor but acceptable (2) or poor and unacceptable (1)


Secondary Outcome Measures :
  1. Respiratory rate [ Time Frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes ]
    Respiratory rate of patient

  2. peripheral arterial oxygen saturation [ Time Frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes ]
    peripheral arterial oxygen saturation(sPO2)

  3. visual analogue scale (VAS) for pain [ Time Frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes ]
    visual analogue scale (VAS) for pain

  4. occurrence of nausea or vomiting [ Time Frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes ]
    occurrence of nausea or vomiting with Rhodes Index

  5. the level of sedation or alertness [ Time Frame: every 15 minutes from the arrival on the recovery room, up to 60 minutes ]
    the level of sedation or alertness with OAA/S scale

  6. Postoperative Quality Recovery Scale (PQRS) [ Time Frame: at baseline (the day before surgery), at 1 hour after surgery, at 6 hours after surgery, at 24 hours after surgery and at 7 days after surgery ]
    physiologic, nociceptive, emotive, cognitive and activities of daily living



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent.

Exclusion Criteria:

  • Known allergy to rocuronuim, cisatracurium or sugammadex
  • Significant liver or kidney dysfunction
  • Any neuromuscular disease
  • Pregnant or breast feeding
  • Indication for rapid sequence induction
  • Inability to give informed consent
  • Patients taking any medication with potential interference with neuromuscular transmission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601508


Contacts
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Contact: SEONGHEON LEE, MD, PhD +82-10-8612-9548 headheadhead@naver.com
Contact: Shiyoung JEONG, MD +82-10-9440-8415

Locations
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Korea, Republic of
Chonnam University Hwasun Hospital Not yet recruiting
Hwasun, Korea, Republic of, 519-763
Contact: Chanhong Park, BsC    +82-61-379-7598    cnuhpch@naver.com   
Sub-Investigator: Seongheon Lee, MD, PhD         
Sub-Investigator: Inje Kim, BsC         
Sub-Investigator: Shi Young Chung, MD         
Principal Investigator: Seongwook Jeong, MD, PhD         
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
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Principal Investigator: SEONGWOOK JEONG, MD, PhD. Chonnam University Hospital

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Responsible Party: Seongwook Jeong, associate professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT02601508     History of Changes
Other Study ID Numbers: CNUHH-2015-135
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015
Keywords provided by Seongwook Jeong, Chonnam National University Hospital:
deep NM block
Surgeon's satisfaction
bridion
Additional relevant MeSH terms:
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Rocuronium
Atracurium
Cisatracurium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nicotinic Antagonists