NCT04529135

The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy

Completed NA Last updated 23 June 2022

What this trial tests

NA trial testing Dexmedetomidine in Gastric Cancer in 68 participants. Completed in 20 June 2022.

Timeline

26 August 2020

Primary endpoint
20 June 2022

20 June 2022

Quick facts

Lead sponsor	Gangnam Severance Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	68
Start date	26 August 2020
Primary completion	20 June 2022
Estimated completion	20 June 2022
Sites	1 location across South Korea

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →
• Remifentanil — full drug profile →

Conditions studied

• Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

Gangnam Severance Hospital

Who can join

Adults 19 to 75, any sex, with Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

"Want to know the effect of dexmedetomidine during opioid free anesthesia on postoperative recovery after gastrectomy. Patients undergoing open gastrectomy are divided into dexmedetomidine group and control(remifentanil) group, administered during surgery, and compared with the speed of postoperative intestinal function recovery. Based on our institution's previous record, the average recovery time was 6 ± 1.4 days. Given that it is clinically significant to reduce recovery time by 20%, Alpha 0.05 and Power 80% require 31 samples per group, and assuming a 10% dropout rate, the total number of samples needed is 68.Subjects are patients aged 19 to 75 who are subject to open gastretomy planned by a gastric cancer. The exclusion criteria include American Society of Anesthesiology grade 3 or higher, patients who have previously been treated for cancer, patients with cancer other than the stomach, patients with drug allergies, weight less than 60kg, BMI \> 30 kg/m2, patients who are unable to communicate and are unable to read consent (e.g., illiteracy, foreigners, etc.). The research method is a Randomized double-blind controlled study, and the assignment of both drugs is unknown and is used to maintain anesthesia in the form of continuous injection during surgery. Primary outcome is the recovery period satisfying the following. 1)intestinal gas passage 2) tolerance of soft bland diet (SBD) for 24 hr. 3) safe ambulation without assistance 4) no requirement iv analgesics after discontinuation of PCA (VAS \<4). 5) no abnormal physical signs or laboratory test. The secondary outcomes are maximum VAS, post-operative hospital stay, complications and readmission rate at 3 months F/U time, post-operative period analgesic requirement, incidence of opioid related side effect.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trial watch: dexmedetomidine in cancer therapy.
   Carnet Le Provost K, Kepp O, Kroemer G, Bezu L. · · 2024 · cited 24× · PMID 38481729 · DOI 10.1080/2162402x.2024.2327143