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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modarate Blockade Group | Active Comparator | Neuromuscular blocking agent, cis-atracurium will be administered after skin incision and reversal agents, pyridostigmine & glycopyrrolate will be given for the recovery. |
|
| Deep Blockade Group | Experimental | Neuromuscular blocking agent, rocuronium will be administered after skin incision and reversal agent, Sugammadex will be given for the recovery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | Continuous infusion of rocuronium for PTC 1 + Sugammadex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical rating SCORE(SRS) | excellent (5), good but not optimal (4), moderate (3), poor but acceptable (2) or poor and unacceptable (1) | every 15 minutes from the pneumoperitoneum, up to 120 minutes till the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate | Respiratory rate of patient | every 15 minutes from the arrival on the recovery room, up to 60 minutes |
| peripheral arterial oxygen saturation | peripheral arterial oxygen saturation(sPO2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SEONGHEON LEE, MD, PhD | Contact | +82-10-8612-9548 | headheadhead@naver.com | |
| Shiyoung JEONG, MD | Contact | +82-10-9440-8415 |
| Name | Affiliation | Role |
|---|---|---|
| SEONGWOOK JEONG, MD, PhD. | Chonnam University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam University Hwasun Hospital | Hwasun | 519-763 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 21, 2020 | |
| Reset | May 1, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 21, 2020 | May 1, 2020 |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| C101584 | cisatracurium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| cis-atracurium | Drug | Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine & Glycopyrrolate |
|
|
| every 15 minutes from the arrival on the recovery room, up to 60 minutes |
| visual analogue scale (VAS) for pain | visual analogue scale (VAS) for pain | every 15 minutes from the arrival on the recovery room, up to 60 minutes |
| occurrence of nausea or vomiting | occurrence of nausea or vomiting with Rhodes Index | every 15 minutes from the arrival on the recovery room, up to 60 minutes |
| the level of sedation or alertness | the level of sedation or alertness with OAA/S scale | every 15 minutes from the arrival on the recovery room, up to 60 minutes |
| Postoperative Quality Recovery Scale (PQRS) | physiologic, nociceptive, emotive, cognitive and activities of daily living | 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 |
| D011083 |
| Polycyclic Compounds |