CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 96 enrolled
Drug / intervention
deep blockdrug
Likely dose
deep block 4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02100280
NCT02100280Phase 4Completed

A Double-blinded, Randomized, Parallel Design Study to Compare the Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy

Seoul National University Bundang Hospital·interventional·Posted Mar 31, 2014·Updated Jan 10, 2024

In Brief

A Phase 4 clinical trial evaluating deep block for Neuromuscular Blockade. Completed, enrolled 96 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 31, 2014
Enrollment StartJun 29, 2014
Primary CompletionJun 14, 2017
Study CompletionJun 16, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.3 years ago

Interventions

deep blockdrug

sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block