Last reviewed · How we verify

NCT03820388

Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia

Completed Phase 4 Results posted Last updated 23 February 2021
What this trial tests

Phase 4 trial testing Propofol 2mg/kg in Surgery in 75 participants. Completed in 13 July 2018.

Timeline
1 December 2017
Primary endpoint
13 July 2018
13 July 2018

Quick facts

Lead sponsorUniversity of California, Davis
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment75
Start date1 December 2017
Primary completion13 July 2018
Estimated completion13 July 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Davis

Who can join

18 and older, any sex, with Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Blood Pressure Primary · 10 minutes after induction (intraoperative)

Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.

GroupValue95% CI
Propofol Group105± 16
Etomidate Group122± 23
Propofol Plus Etomidate Group117.88± 18
Heart Rate Primary · 10 minutes after induction (intraoperative)

Heart Rate changes during induction (Beats Per min)

GroupValue95% CI
Propofol Group77± 17
Etomidate Group74± 12
Propofol Plus Etomidate Group74± 11
Pain at Injection Site Secondary · intraoperative

Pain on injection will be measured using 4 graded scale; 0 = no pain, 1 = verbal complaint of pain, 2 = withdrawal of arm, 3 = both verbal complaint and withdrawal of arm.

GroupValue95% CI
Propofol Group7
Etomidate Group0
Propofol Plus Etomidate Group0
Myoclonic Movements Secondary · intraoperative

The incidence and degree of myoclonic movements also recorded as follows: 0 = no myoclonic movements, 1 = minor myoclonic movements, 2 = moderate myoclonic movements, 3 = major myoclonic movements.

GroupValue95% CI
Propofol Group1
Etomidate Group6
Propofol Plus Etomidate Group1
Post-operative Nausea and Vomiting Secondary · 24 hours post-operation

Presence of post-operative nausea or vomiting (yes/no).

GroupValue95% CI
Propofol Group0
Etomidate Group1
Propofol Plus Etomidate Group2
Sedation Depth Secondary · 30 minutes post-induction

Sedation depth using bispectral index (BIS). BIS scores range from 0-100. A value of 0 indicates no EEG activity, 40-60 indicates an appropriate level of general anesthesia, and 90-100 is typical of a state of wakefulness.

GroupValue95% CI
Propofol Group30± 8.4
Etomidate Group38± 11
Propofol Plus Etomidate Group38± 13
Eyelash Reflex Disappear Time Secondary · Post induction, up to 1 hour

Time to disappearance of eyelash reflex after induction.

GroupValue95% CI
Propofol Group31.9± 8.3
Etomidate Group34.5± 7.5
Propofol Plus Etomidate Group32.4± 9
Intubation Time Secondary · Up to 2 hours

Duration of orotracheal intubation.

GroupValue95% CI
Propofol Group92± 9.6
Etomidate Group95± 8.9
Propofol Plus Etomidate Group93± 9.5

Sponsor's own description

Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Surgery

Currently open trials in the same condition.

Other University of California, Davis trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03820388.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing