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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| deep neuromuscular blockade | Experimental | 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 |
|
| moderate neuromuscular blockade | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | rocuronium is a neuromuscular blocking agent with a duration of 40 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative major respiratory complications | incidence of pneumonia and atelectasis | from end of surgery to discharge, at an average of 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| maximal airway pressure | airway pressure is titrated to as low as possible as long as the end tidal carbon dioxide partial pressure is lower than 40 mmHg | from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours |
| minimal cerebral oxygen saturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihong Lu | Contact | 86-13891975018 | 13891975018 | deerlu23@163.com |
| Hailong Dong | Contact | 86-84775337 | 8613891975018 | hldong6@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhihong Lu | Xijing Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25684372 | Background | 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. | |
| 24240315 | Background |
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After publishing, data of the primary endpoint and second endpoints can be shared with other researchers
When the results have been published in peer-reviewed journals, the data will be available. The planned time frame will be 5 years.
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Muscle relaxant will be given by a specific investigator that is not involved in anesthesia and outcome assessment
|
| continuous infusion | Other | rocuronium is continuously infused |
|
|
| intermittent injection | Other | rocuronium is intermittently given |
|
|
cerebral oxygen saturation is continuously monitored during surgery |
| from start of surgery to end of surgery, at an average of 3.5 hours |
| maximal intraocular pressure | intraocular pressure is monitored every 10 minutes during surgery | from start of surgery to end of surgery, at an average of 3.5 hours |
| number of surgeon asking for improving muscle relax | when the surgeon is unsatisfied with the muscle relax, he can tell the anesthetist | from start of surgery to end of surgery, at an average of 3.5 hours |
| time to extubation | criteria of extubation: spontaneous respiratory rate>10 per minute and end tidal carbon dioxide partial pressure<45mmHg | from end of sevoflurane inhalation to extubation, at an average of 20 minutes |
| incidence of nausea and vomiting in post-anesthesia care unit | from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes |
| incidence of shoulder pain in 24 hours after surgery | from end of surgery to 24 hours after surgery |
| incidence of residual neuromuscular blockade in the post-anesthesia care unit | residual neuromuscular blockade is defined as time of head-lift or limb-lift<10 seconds | from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes |
| visual analogue scale at 24 hours after surgery | the patients are asked to mark the score they feel, 0 is no pain,100 is untolerated pain | end of surgery to 24 hours after surgery |
| expense after surgery | the expense from immediately after surgery to discharge | end of the surgery to discharge,at an average of 4 days |
| satisfaction score of the patients | the patient is asked to give a score between 0 and 10, 0 means not satisfied,10 means totally satisfied. | from end of surgery to discharge,at an average of 4 days |
| 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. |
| 28803124 | Background | 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. |
| 27936214 | Background | 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. |
| D011083 |
| Polycyclic Compounds |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |