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Phase 4 N=96 Randomized Quadruple-blind Other

The Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy

Neuromuscular Blockade

Enrolled (actual)
96
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: IL-6 — 84; 70.14 pg / ml

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
deep block (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Seoul National University Bundang Hospital
Primary completion
Jun 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
IL-6
84; 70.14
SECONDARY
TNF-α
1.33; 1.66
SECONDARY
IL-1β
0.34; 0.27
SECONDARY
IL-8
29.6; 29.5
SECONDARY
CRP
12.2; 10.6

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.

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists grade 1 or 2
  • Scheduled for elective laparoscopic gastrectomy

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02100280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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