Trial Outcomes & Findings for Emergence From Anesthesia in Anterior Temporal Lobectomy and Amygdalohippocampectomy Patients (NCT NCT02360098)
NCT ID: NCT02360098
Last Updated: 2020-07-13
Results Overview
Comparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups
COMPLETED
36 participants
1 day
2020-07-13
Participant Flow
all patients will be seen by the anesthesiologists in the pre-anesthesia consult clinic.
Intraoperatively, all patients will have standard monitoring consisting of electrocardiography (ECG), pulse oximetry, end-tidal carbon dioxide (ETCO2), invasive and non-invasive blood pressure, temperature, urine output, depth of anesthesia (Entropy) and end tidal anesthetic agent concentration.
Participant milestones
| Measure |
Agitated Emergence and Smooth Emergence
Number of consented patients to participate in the study
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Agitated Emergence and Smooth Emergence
Number of consented patients to participate in the study
|
|---|---|
|
Overall Study
Physician Decision
|
7
|
Baseline Characteristics
Sex/Gender data were not collected.
Baseline characteristics by cohort
| Measure |
Agitated Emergence
n=9 Participants
Demographic variables of patients woke up agitated from anesthesia
|
Smooth Emergence
n=20 Participants
Demographic variables of patients with smooth wake up from anesthesia
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
33 years
STANDARD_DEVIATION 11 • n=9 Participants
|
36 years
STANDARD_DEVIATION 13 • n=20 Participants
|
34.5 years
STANDARD_DEVIATION 12 • n=29 Participants
|
|
Sex/Gender, Customized
Sex/Gender data were not collected.
|
0 Participants
Sex/Gender data were not collected.
|
0 Participants
Sex/Gender data were not collected.
|
0 Participants
Sex/Gender data were not collected.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
76 Kg
STANDARD_DEVIATION 15 • n=9 Participants
|
75 Kg
STANDARD_DEVIATION 19 • n=20 Participants
|
75.5 Kg
STANDARD_DEVIATION 17 • n=29 Participants
|
|
Height
|
174 cm
STANDARD_DEVIATION 10 • n=9 Participants
|
170 cm
STANDARD_DEVIATION 9 • n=20 Participants
|
172 cm
STANDARD_DEVIATION 8 • n=29 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Comparison of volumes of the hippocampus, thalamus and amygdala in both groups
Comparison of volumes of the hippocampus, thalamus and amygdala between Agitated and Smooth emergence groups
Outcome measures
| Measure |
Agitated Emergence
n=9 Participants
Comparison of volumes of the hippocampus, thalamus and amygdala
|
Smooth Emergence
n=20 Participants
Comparison of volumes of the hippocampus, thalamus and amygdala
|
|---|---|---|
|
Volumes of the Hippocampus, Thalamus and Amygdala
ipsilateral amygdala
|
1331 mm3
Standard Deviation 272
|
1295 mm3
Standard Deviation 285
|
|
Volumes of the Hippocampus, Thalamus and Amygdala
ipsilateral hippocampus
|
3578 mm3
Standard Deviation 344
|
3903 mm3
Standard Deviation 516
|
|
Volumes of the Hippocampus, Thalamus and Amygdala
contralateral hippocampus
|
3479 mm3
Standard Deviation 452
|
3525 mm3
Standard Deviation 569
|
|
Volumes of the Hippocampus, Thalamus and Amygdala
ipsilateral thalamus
|
7311 mm3
Standard Deviation 663
|
7479 mm3
Standard Deviation 856
|
|
Volumes of the Hippocampus, Thalamus and Amygdala
contralatera thalamus l
|
7608 mm3
Standard Deviation 908
|
7631 mm3
Standard Deviation 799
|
|
Volumes of the Hippocampus, Thalamus and Amygdala
contralateral amygdala
|
1321 mm3
Standard Deviation 223
|
1260 mm3
Standard Deviation 230
|
Adverse Events
Agitated Emergence and Smooth Emergence
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place