Conscious Sedation for Epilepsy Surgery
Propofol-dexmedetomidine Versus Propofol-remifentanil Conscious Sedation for Awake Craniotomy During Epilepsy Surgery
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
Sixty patients were randomly allocated into two groups, group PD and group PR, thirty patients in each group. Patients in PD group received propofol and dexmedetomidine intravenous infusion and patients in PR group received propofol and remifentanil intravenous infusion. Sedation score and patients' satisfaction, surgeon satisfaction, heart rate, mean arterial blood pressure, oxygen saturation, and side effects such as respiratory depression, nausea, vomiting, airway obstruction, and oxygen desaturation were recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
December 9, 2016
CompletedResults Posted
Study results publicly available
October 9, 2020
CompletedOctober 9, 2020
September 1, 2020
2.5 years
November 28, 2016
August 10, 2020
September 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients Satisfaction
Patient's satisfaction was recorded using a score ranging from 0 for not satisfied to 10 for totally satisfied.
1 hour after the operation
Study Arms (2)
Propofol-dexmedetomidine
OTHERPropofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)
Propofol-remifentanil
OTHERPropofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)
Interventions
With local anaesthetic for skin infiltration.
Eligibility Criteria
You may qualify if:
- Patients require conscious sedation for epilepsy surgery
You may not qualify if:
- Patients refusal, allergy to drugs used, and uncooperative patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Ezzeldin Ibrahim, Professor of Anaesthesia
- Organization
- Menoufia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor in anaesthesia, intensive care, and pain medicine
Study Record Dates
First Submitted
November 28, 2016
First Posted
December 9, 2016
Study Start
August 1, 2013
Primary Completion
February 1, 2016
Study Completion
April 1, 2016
Last Updated
October 9, 2020
Results First Posted
October 9, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share