Trial Outcomes & Findings for Conscious Sedation for Epilepsy Surgery (NCT NCT02988050)
NCT ID: NCT02988050
Last Updated: 2020-10-09
Results Overview
Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
1 hour after the operation
Results posted on
2020-10-09
Participant Flow
Patients were excluded if they refused to be included in the study.
Participant milestones
| Measure |
Propofol-dexmedetomidine
Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)
Dexmedetomidine: Dexmedetomidine used for conscious sedation.
Propofol: Used for conscious sedation.
Bupivacaine: Local anaesthetics
Lidocaine: Local anaesthetic
Epinephrine: With local anaesthetic for skin infiltration.
|
Propofol-remifentanil
Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)
Remifentanil: Remifentanil used for conscious sedation.
Propofol: Used for conscious sedation.
Bupivacaine: Local anaesthetics
Lidocaine: Local anaesthetic
Epinephrine: With local anaesthetic for skin infiltration.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Conscious Sedation for Epilepsy Surgery
Baseline characteristics by cohort
| Measure |
Propofol-dexmedetomidine
n=30 Participants
Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)
Dexmedetomidine: Dexmedetomidine used for conscious sedation.
Propofol: Used for conscious sedation.
Bupivacaine: Local anaesthetics
Lidocaine: Local anaesthetic
Epinephrine: With local anaesthetic for skin infiltration.
|
Propofol-remifentanil
n=30 Participants
Propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)
Remifentanil: Remifentanil used for conscious sedation.
Propofol: Used for conscious sedation.
Bupivacaine: Local anaesthetics
Lidocaine: Local anaesthetic
Epinephrine: With local anaesthetic for skin infiltration.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
33 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hour after the operationPatient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.
Outcome measures
| Measure |
Conscious sedation1
n=30 Participants
Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)
Dexmedetomidine: Dexmedetomidine used for conscious sedation.
Propofol: Used for conscious sedation.
Bupivacaine: Local anaesthetics
Lidocaine: Local anaesthetic
Epinephrine: With local anaesthetic for skin infiltration.
|
Conscious sedation2
n=30 Participants
propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)
Remifentanil: Remifentanil used for conscious sedation.
Propofol: Used for conscious sedation.
Bupivacaine: Local anaesthetics
Lidocaine: Local anaesthetic
Epinephrine: With local anaesthetic for skin infiltration.
|
|---|---|---|
|
Patients Satisfaction
|
6.33 score on a scale
Standard Deviation 1.36
|
6.45 score on a scale
Standard Deviation 1.41
|
Adverse Events
Propofol-dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol-remifentanil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Ezzeldin Ibrahim, Professor of Anaesthesia
Menoufia University
Phone: 00201006303178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place