Unique ID issued by UMIN | UMIN000015028 |
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Receipt number | R000017456 |
Scientific Title | Is profound muscle relaxation necessary for laparoscopic surgery? |
Date of disclosure of the study information | 2014/09/03 |
Last modified on | 2019/01/09 06:35:19 |
Is profound muscle relaxation necessary for laparoscopic surgery?
Is profound muscle relaxation necessary for laparoscopic surgery?
Is profound muscle relaxation necessary for laparoscopic surgery?
Is profound muscle relaxation necessary for laparoscopic surgery?
Japan |
cholelithiasis
Hepato-biliary-pancreatic surgery |
Others
NO
To compare surgical conditions during laparoscopic cholecystectomy in patients with deep neuromuscular block and moderate block.
Efficacy
The proportion of overall excellent relaxation.
The patient's condition is described as overall excellent relaxation if all the scores obtained are 4. Surgical conditions are assessed by surgeons using a four-point surgical rating scale.
Mean surgical rating score, mean intraabdominal pressure, the proportion of operations completed at pneumoperitoneum 8 mmHg, the number of times of additional dosage of rocuronium in case of inadequate surgical conditions.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Treatment
Medicine |
General anesthesia is induced propofol 2mg/kg and remifentanil 0.5 microgram/kg/min IV. After calibration of the TOF-Watch, rocuronium 0.6mg/kg is injected to facilitate tracheal intubation. Anesthesia is maintained with IV infusion of propofol and remifentanil. Propofol dosing is such that BIS values remained within the range of 40-60. TOF measurement is made every 6 minutes during surgery. When TOF count is >2, a bolus dose of rocuronium 0.1mg/kg is administrated. Target TOF count is 1 to 2. During the laparoscopic procedure, the surgeon scored the surgical working conditions at 20 min intervals according to a four-point surgical rating scale. In case inadequate surgical conditions, intraabdominal pressure is increased to 12mmHg. If still inadequate, a bolus dose of rocuronium 0.2mg/kg is given. When gallbladder is removed, infusion of rocuronium is stopped.
General anesthesia is induced propofol 2mg/kg and remifentanil 0.5 microgram/kg/min IV. After calibration of the TOF-Watch, rocuronium 1.0mg/kg is injected to facilitate tracheal intubation. Anesthesia is maintained with IV infusion of propofol and remifentanil. Propofol dosing is such that BIS values remained within the range of 40-60. PTC measurement is made every 6 minutes during surgery. When PTC is >2, a bolus dose of rocuronium 0.2mg/kg is administrated. Target PTC is 0 to 2. During the laparoscopic procedure, the surgeon scored the surgical working conditions at 20 min intervals according to a four-point surgical rating scale. In case inadequate surgical conditions, intraabdominal pressure is increased to 12mmHg. If still inadequate, a bolus dose of rocuronium 0.2mg/kg is given. When gallbladder is removed, infusion of rocuronium is stopped.
18 | years-old | <= |
Not applicable |
Male and Female
Patients scheduled for elective laparoscopic cholecystectomy.
neuromuscular disease, allergy to medication to be used during anesthesia, significant liver or renal dysfunction, apoplexy, a body mass index of >30, inability to give informed consent.
88
1st name | |
Middle name | |
Last name | Takaya Hojo |
Tokyo Metropolitan Tama Medical Center
Department of Anaesthesia
2-8-29 Musashidai, Fuchu-shi, Tokyo
042-323-5111
ha_hi_hu_he_hojo@yahoo.co.jp
1st name | |
Middle name | |
Last name | Takaya Hojo |
Tokyo Metropolitan Tama Medical Center
Department of Anaesthesia
2-8-29 Musashidai, Fuchu-shi, Tokyo
042-323-5111
ha_hi_hu_he_hojo@yahoo.co.jp
Tokyo Metropolitan Tama Medical Center
Tokyo Metropolitan Government
Local Government
NO
2014 | Year | 09 | Month | 03 | Day |
Unpublished
Completed
2014 | Year | 09 | Month | 03 | Day |
2014 | Year | 09 | Month | 03 | Day |
2018 | Year | 01 | Month | 24 | Day |
2018 | Year | 01 | Month | 24 | Day |
2014 | Year | 09 | Month | 02 | Day |
2019 | Year | 01 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017456
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