CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 746 enrolled
Drug / intervention
Ketamine (0.5 mg/kg) +2 moredrug
Likely dose
Ketamine (0.5 mg/kg)from 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/NCT01690988
NCT01690988Phase 3Completed
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The Prevention of Delirium and Complications Associated With Surgical Treatments Multi Center Clinical Trial

Washington University School of Medicine·interventional·Posted Sep 24, 2012·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating Ketamine (0.5 mg/kg), Normal Saline (placebo), and 1 other intervention for Delirium. Completed, enrolled 746 participants across 1 site.

Detailed Summary

Delirium is a medical term or condition that includes a temporary inability to focus attention and to think clearly. Delirium occurs commonly (10% to 70%) in patients older than 60 undergoing large surgeries. The purpose of this study is to test rigorously whether a drug called ketamine can decrease the chance that patients will experience delirium after their surgery. The investigators are also testing whether ketamine decreases postoperative pain, postoperative opioid consumption, postoperative nausea and vomiting, ICU and hospital length of stay, and adverse outcomes (e.g. hallucinations and nightmares).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelirium
CountriesUnited States
CollaboratorsAsan Medical Center, Weill Medical College of Cornell University, Harvard Medical School (HMS and HSDM), Medical College of Wisconsin, Memorial Sloan Kettering Cancer Center, Post Graduate Institute of Medical Education and Research, Chandigarh, University of Bern, University of Michigan, University of Manitoba, University Health Network, Toronto, Virginia Mason Hospital/Medical Center

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 24, 2012
Enrollment StartFeb 1, 2014
Primary CompletionJun 26, 2016
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.8 years ago

Interventions

Ketamine (0.5 mg/kg)drug

Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.

Normal Saline (placebo)drug

Normal saline IV following induction of anesthesia or administration of sedative medications

Ketamine (1 mg/kg)drug

Low dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.