- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02580188
The Effect of Deep Neuromuscular Block on Surgical Condition During Laparoscopic Colorectal Surgery (DEEPCOL)
12. marts 2019 opdateret af: BON WOOK KOO, Seoul National University Bundang Hospital
This study is a randomized, controlled, double-blinded, and parallel design study.
A total 96 patients were randomized to receive a deep block or a moderate block scheduled for elective laparoscopic colorectal surgery.
Investigators estimated the proportion of intra-abdominal pressure(IAP) alarm and surgical rating score.
Studieoversigt
Detaljeret beskrivelse
Patients >18 years of age with an america society of anesthesiologist classification of I or II who were scheduled to undergo elective laparoscopic colorectal surgery were included.
The exclusion criteria were a history of neuromuscular, renal, or hepatic disease, a history of low abdominal surgery; treatment with drugs known to interfere with neuromuscular function.
Patients were randomised to either the moderate or deep neuromuscular blockade group using Random Allocation Software (version 1.0).
Premedication with intravenous midazolam at 0.03 mg/kg was performed in the reception area.
In the operating room, routine monitoring was performed, including electrocardiography, non-invasive arterial pressure measurements, and pulse oximetry.
Additionally, acceleromyography was applied to monitor the response of the corrugator supercilii muscle.
Neuromuscular management and monitoring were performed according to the Good Clinical Research Practice guidelines.
After the induction of anaesthesia with propofol and remifentanil using target-controlled infusers and before rocuronium administration, the TOF-Watch-SX was calibrated and stabilised; a 50-Hz tetanic stimulation was applied for 5 s, the TOF-Watch-SX was calibrated, and a series of train-of-four (TOF) measurements were documented for >2 min until a stable baseline was obtained (<5% variation in the TOF ratios).
Next, intravenous rocuronium at 0.6 mg/kg was administered, and tracheal intubation was performed after confirmation of relaxation.
Anesthesia was maintained with desflurane and target-controlled infusion of remifentanil while monitoring the bispectral index.
A continuous dose of intravenous rocuronium (10-60 mg/hr) was used to maintain moderate (TOF count of 1 or 2) or deep (post-tetanic count [PTC] of 1 or 2) neuromuscular blockade.
The IAP alarm(IAP>15mmHg) rate were checked.
Any movement during the operation as reported by the surgeon or anaesthesiologist was recorded.
At the end of the operation, the surgeon rated the surgical condition on a 5-point scale.
Patients in the moderate group were reversed with neostigmine at 50 µg/kg and glycopyrrolate at 10 µg/kg at a TOF count of 1 or 2, and patients in the deep group were reversed with intravenous sugammadex at 4 mg/kg at PTC of 1 or 2. The time from administration of the reversal agents to a TOF ratio of 0.9 was recorded.
Postoperative pain and opioid consumption were evaluated at 24, 48h postoperatively.
Postoperative nausea and/or vomiting, dry mouth, were also evaluated at the same time points.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
70
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- American Society of Anesthesiologists grade 1 or 2
- Scheduled for elective laparoscopic Colorectal surgery
Exclusion Criteria:
- Severe respiratory or cardiac disease
- Severe hepatic or renal function impairment
- On medications affecting neuromuscular function
- Known allergy to the drugs to be used
- Pregnant
- Malignant hyperthernia
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Moderate block
Maintenance dose of 0.15-0.3
mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block).
At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
|
|
Eksperimentel: Deep block
Maintenance dose of 0.4-0.9
mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
|
Maintenance dose of 0.4-0.9
mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg
Tidsramme: intraoperative, an averrage of 3 hour
|
Intra-abdominal pressure was maintained at 12 mmHg during pneumoperitoneum(using the carbon dioxide gas insufflation) and the pressure alarm for IAP was set at < 15 mmHg. Intra-abdominal pressure is measured in a separate machine connected to a carbon dioxide gas injection line. |
intraoperative, an averrage of 3 hour
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
Tidsramme: 24hr after end of operation
|
Postoperative pain is controlled by IV patient controlled analgesia using fentanyl.
If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.
|
24hr after end of operation
|
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
Tidsramme: 48hr after end of operation
|
Postoperative pain is controlled by IV patient controlled analgesia using fentanyl.
If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.
|
48hr after end of operation
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Ah-Young Oh, MD.,Ph.D., Seoul National Univ. Bundang Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
24. marts 2015
Primær færdiggørelse (Faktiske)
16. juni 2016
Studieafslutning (Faktiske)
18. juni 2016
Datoer for studieregistrering
Først indsendt
30. september 2015
Først indsendt, der opfyldte QC-kriterier
19. oktober 2015
Først opslået (Skøn)
20. oktober 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. marts 2019
Sidst verificeret
1. marts 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- DNMBC-SNUBH
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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