Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02100280 |
| Other study ID # |
SNUBH-NMB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
June 29, 2014 |
| Est. completion date |
June 16, 2017 |
Study information
| Verified date |
January 2024 |
| Source |
Seoul National University Bundang Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is a multicenter, randomized, controlled, double-blinded, and parallel design
study. A total of 96 patients were decided to be recruited considering a 10% dropout rate.
Patients are randomized to receive a deep block or a moderate block. The randomization
numbers are generated using a computer-generated randomization code (1) and are sealed in the
opaque envelope until they are handed over to the anesthesiologist in charge of anesthesia
management after the induction of anesthesia. Patients, surgeons reporting the scale of
surgical status, and another researcher analysing the cytokines levels are blinded to the
patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective
laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease,
hepatic or renal function impairment, on medications affecting neuromuscular function, and
with known allergy to the drugs to be used are excluded.
Description:
Induction and maintenance of anesthesia
Premedication is done with midazolam 0.03 mg/kg IV at reception area. Anesthesia is induced
and maintained with intravenous propofol, remifentanil, and rocuronium. The dose of propofol
is adjusted to maintain BIS value to 40-60, remifentanil to maintain blood pressure within
20% of preoperative value, and rocuronium to maintain PTC 1-2 (deep block) or TOF1-2
(moderate block). The monitoring consists of ECG, NIBP, pulse oximetry, temperature, ETCO2,
BIS, and neuromuscular monitoring with acceleromyography (TOF-Watch SXTM, Organon Ltd.,
Dublin, Ireland).
Management and monitoring of neuromuscular block
After induction of anesthesia, continuous neuromuscular monitoring is started after
calibration and stabilization of the signal as recommended by good clinical research
practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2.
After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal
intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the
maintenance of PTC1-2 (deep block) or TOF1-2 (moderate block). At the end of surgery,
sugammadex 4 mg/kg for deep block group or neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg
for moderate block group are administered IV for reversal of neuromuscular block.
Evaluation of surgical conditions
A 5-point surgical rating scale (1 = excellent, 2 = good, 3 = acceptable, 4 = poor, 5 =
extremely poor) is rated by the surgeon who is in charge of the patient's operation and is
blind to the patient's group assignment. Intraoperative patient movement reported by surgeon,
checked by restoration of spontaneous respiration or sudden increase in PIP, and any other
movement are also recorded.
Measurement of cytokines and acute phase reactants
Blood samples are collected from the antecubital vein of the arm not used for IV infusion
preoperatively, at the end of peritoneal closure, and 1, 2, & 48 hr after the end of
operation for analysis of TNF-α, IL-1β, 6, 8 and CRP. The blood samples are collected at test
tubes and sent to the laboratory on ice. Cytokines are analyzed with enzyme-linked
immunosorbent assay and CRP is determined by an institutional chemistry analyzer.
Postoperative pain measurement
Postoperative pain is evaluated by verbal numerical rating scale (VNRS, 0 = no pain, 10 = the
severest pain imaginable) at postoperative 1, 2, 6, 24, and 48 hr. 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. The amount of fentanyl used and additional analgesic drugs used are reported.
