Number of Participants Who Experienced an Adverse Event
Primary
· Up to 48 hours post anesthesia.
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 2 | |
| Propofol | 2 | |
| Sevoflurane | 3 |
Last reviewed · How we verify
NCT02053766
Anesthesia in Patients With Mitochondrial Disease
Terminated
NA
Results posted
Last updated 28 August 2024
What this trial tests
NA trial testing Sevoflurane in Mitochondrial Diseases in 19 participants. Terminated before completion.
Timeline
10 January 2014
Primary endpoint
1 October 2020
1 October 2020
1 October 2020
Quick facts
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 19 |
| Start date | 10 January 2014 |
| Primary completion | 1 October 2020 |
| Estimated completion | 1 October 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sevoflurane — full drug profile →
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- Propofol (Propofol) — full drug profile →
Conditions studied
- Mitochondrial Diseases — all drugs for Mitochondrial Diseases →
Sponsor
The University of Texas Health Science Center, Houston
Who can join
Adults 1 Day to 17, any sex, with Mitochondrial Diseases. 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 Glucose Level
Secondary
· Baseline
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 88.66 | ± 15.29 |
| Propofol | 89.20 | ± 4.76 |
| Sevoflurane | 83.66 | ± 10.2 |
Blood Glucose Level
Secondary
· 24 hours post-operative
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 87 | ± 7 |
| Propofol | 81.50 | ± 13.43 |
| Sevoflurane | 93.75 | ± 16.50 |
Serum pH
Secondary
· Baseline
The pH scale measures how acidic of alkaline a substance is and ranges from 0 to 14, where 7 is neutral, 14 is the most alkaline and 0 is the most acidic.
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 7.39 | ± 7.37 |
| Propofol | 7.36 | ± 0.05 |
| Sevoflurane | 7.37 | ± 0.02 |
Serum pH
Secondary
· 24 hours post-operative
The pH scale measures how acidic of alkaline a substance is and ranges from 0 to 14, where 7 is neutral, 14 is the most alkaline and 0 is the most acidic.
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 7.36 | ± 0.05 |
| Propofol | 7.40 | ± NA |
| Sevoflurane | 7.32 | ± 0.04 |
Serum Bicarbonate
Secondary
· Baseline
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 25.50 | ± 1.91 |
| Propofol | 24.04 | ± 3.66 |
| Sevoflurane | 25.23 | ± 2.51 |
Serum Bicarbonate
Secondary
· 24 hours post-operative
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 24.33 | ± 4.16 |
| Propofol | 20 | ± NA |
| Sevoflurane | 26.5 | ± 2.12 |
Serum Lactate
Secondary
· Baseline
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 1.28 | ± 0.44 |
| Propofol | 0.82 | ± 0.25 |
| Sevoflurane | 1.36 | ± 0.58 |
Serum Lactate
Secondary
· 24 hours post-operative
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 2.76 | ± 0.47 |
| Propofol | 1.15 | ± 0.36 |
| Sevoflurane | 2.50 | ± 0.65 |
Serum Pyruvate
Secondary
· Baseline
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 0.72 | ± 0.47 |
| Propofol | 1.06 | ± 0.36 |
| Sevoflurane | 1.03 | ± 0.65 |
Serum Pyruvate
Secondary
· 24 hours post-operative
| Group | Value | 95% CI |
|---|---|---|
| Dexmedetomidine (Precedex®) | 1.34 | ± 0.85 |
| Propofol | 1.32 | ± NA |
| Sevoflurane | 1.42 | ± 0.69 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 48 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Sevoflurane
Serious: 0/6 (0%)
Deaths: 0/6
Dexmedetomidine (Precedex®)
Serious: 0/7 (0%)
Deaths: 0/7
Propofol
Serious: 0/6 (0%)
Deaths: 0/6
Other adverse events (8 terms — click to expand)
| Reaction | System | Sevoflurane | Dexmedetomidine (Precedex®) | Propofol |
|---|---|---|---|---|
| Vomiting | General disorders | — | — | — |
| Fever | General disorders | — | — | — |
| lethargy | General disorders | — | — | — |
| tachycardia | Cardiac disorders | — | — | — |
| lower back pain | General disorders | — | — | — |
| Nausea | General disorders | — | — | — |
| mood change | General disorders | — | — | — |
| feeding difficulties | General disorders | — | — | — |
Data from ClinicalTrials.gov NCT02053766 adverse events section.
Sponsor's own description
This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02053766
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02053766 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
- Last refreshed: 28 August 2024
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/NCT02053766.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing