Muscle Relax Affects Outcomes of Robotic Surgery (MORE)
29 oktober 2018 uppdaterad av: Zhihong LU, Air Force Military Medical University, China
Effect of Neuromuscular Blockade Protocol on Perioperative Outcomes of Robotic Laparoscopic Surgery
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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
192
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- patients scheduled for elective robotic laparoscopic surgery under general anesthesia
- American Society of Anesthesiologists status 1-2
- Body mass index of 18-30kg/m2
- Patients scheduled to be positioned in trendelenburg position during surgery
Exclusion Criteria:
- Patients allergic to rocuronium
- Patients with neuromuscular dysfunction
- Patients with existed pulmonary diseases
- Patients with hepatic or renal dysfunction
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: deep neuromuscular blockade
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
|
rocuronium is a neuromuscular blocking agent with a duration of 40 minutes
Andra namn:
rocuronium is continuously infused
Andra namn:
|
|
Experimentell: moderate neuromuscular blockade
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
|
rocuronium is a neuromuscular blocking agent with a duration of 40 minutes
Andra namn:
rocuronium is intermittently given
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
incidence of postoperative major respiratory complications
Tidsram: from end of surgery to discharge, at an average of 4 days
|
incidence of pneumonia and atelectasis
|
from end of surgery to discharge, at an average of 4 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
maximal airway pressure
Tidsram: from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours
|
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
Tidsram: from start of surgery to end of surgery, at an average of 3.5 hours
|
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
Tidsram: from start of surgery to end of surgery, at an average of 3.5 hours
|
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
Tidsram: from start of surgery to end of surgery, at an average of 3.5 hours
|
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
Tidsram: from end of sevoflurane inhalation to extubation, at an average of 20 minutes
|
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
Tidsram: from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
|
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
Tidsram: from end of surgery to 24 hours after surgery
|
from end of surgery to 24 hours after surgery
|
|
|
incidence of residual neuromuscular blockade in the post-anesthesia care unit
Tidsram: from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
|
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
Tidsram: end of surgery to 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
Tidsram: end of the surgery to discharge,at an average of 4 days
|
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
Tidsram: from end of surgery to discharge,at an average of 4 days
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Zhihong Lu, Xijing Hospital
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
10 november 2018
Primärt slutförande (Förväntat)
10 november 2019
Avslutad studie (Förväntat)
10 november 2019
Studieregistreringsdatum
Först inskickad
28 oktober 2018
Först inskickad som uppfyllde QC-kriterierna
29 oktober 2018
Första postat (Faktisk)
31 oktober 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- XJH-A-20180701
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Tidsram för IPD-delning
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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- SAV
- ICF
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