Conscious Sedation for Epilepsy Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02988050
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Information provided by (Responsible Party):
Dr Ezzeldin Ibrahim, Menoufia University

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Remifentanil Drug: Dexmedetomidine Drug: Propofol Drug: Bupivacaine Drug: Lidocaine Drug: Epinephrine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Propofol-dexmedetomidine Versus Propofol-remifentanil Conscious Sedation for Awake Craniotomy During Epilepsy Surgery
Study Start Date : August 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Conscious sedation1
Propofol-dexmedetomidine Bupivacaine; Lidocaine (local anaesthetics) Epinephrine (with local anaesthetics for skin infiltration)
Drug: Dexmedetomidine
Dexmedetomidine used for conscious sedation.

Drug: Propofol
Used for conscious sedation.

Drug: Bupivacaine
Local anaesthetics

Drug: Lidocaine
Local anaesthetic

Drug: Epinephrine
With local anaesthetic for skin infiltration.

Conscious sedation2
propofol-remifentanil Bupivacaine; Lidocaine Epinephrine (with local anaesthetics for skin infiltration)
Drug: Remifentanil
Remifentanil used for conscious sedation.

Drug: Propofol
Used for conscious sedation.

Drug: Bupivacaine
Local anaesthetics

Drug: Lidocaine
Local anaesthetic

Drug: Epinephrine
With local anaesthetic for skin infiltration.

Primary Outcome Measures :
  1. Patients satisfaction [ Time Frame: Peri-operatively ]
    Patient's satisfaction score was recorded using a score ranging from 0 not satisfied and 10 totally satisfied. The score was done using a questioner designed by the researchers.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients require conscious sedation for epilepsy surgery

Exclusion Criteria:

  • Patients refusal, allergy to drugs used, and uncooperative patients.

Responsible Party: Dr Ezzeldin Ibrahim, Assistant Professor in anaesthesia, intensive care, and pain medicine, Menoufia University Identifier: NCT02988050     History of Changes
Other Study ID Numbers: MenoufiaU2016
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr Ezzeldin Ibrahim, Menoufia University:
Epilepsy Surgery
Conscious sedation

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics, Local
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists