CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 712 enrolled
Drug / intervention
Dexmedetomidine +1 moredrug
Likely dose
Dexmedetomidine 160 mlfrom 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/NCT03629262
NCT03629262Phase 4Completed

Impact of Dexmedetomidine Supplemented Intravenous Analgesia on Postoperative Delirium and Long-term Outcomes in Elderly After Orthopedic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial

Peking University First Hospital·interventional·Posted Aug 14, 2018·Updated Jul 31, 2025

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine and Placebo for Elderly and 5 related conditions. Completed, enrolled 712 participants across 2 sites.

Detailed Summary

Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. The investigators hypothesize that, for elderly patients after orthopedic surgery, dexmedetomidine supplemented intravenous analgesia can reduce the incidence of delirium and improve the long-term outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartOct 28, 2018
Primary CompletionDec 6, 2019
Study CompletionDec 6, 2022
TodayJul 1, 2026
Enrollment to primary: 1.1 yearsPosted 7.9 years ago

Interventions

Dexmedetomidinedrug

Patients in this group receive patient-controlled intravenous analgesia for 1-3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and sufentanil (1.25 ug/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes.

Placebodrug

Patients in this group receive patient-controlled intravenous analgesia for 1-3 days after surgery. The formula is a mixture of placebo and sufentanil (1.25 ug/m), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes.