Patients scheduled for supratentorial craniotomy or brainstem surgery with intraoperative monitoring of motor evoked potentials (MEP).
Conditions
Interventions
Trade Name: Dexdor
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-6
Current Sponsor code: DEXDOR
Concentration unit: µg/ml microgram(s)/millilitr
Sponsors
Consorci Parc de Salut Mar
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Male and females over 18 years. 2- Patients undergoing supratentorial craniotomy or brainstem surgery due to tumors located in these areas. 3- Patients who have given the informed written consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients with hypovolemic shock or atrioventricular block Patients with liver disease ( altered transaminases) Motor and sensory deficit prior preoperative anaesthetic evaluation Moderate- severe renal insufficiency( creatinine clearance< 60 ml/min) Allergy or hypersensitivity to drugs or excipients used in the study Pregnancy Patients who have entered in other study, three months before surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: During craniotomy procedures with monitoring of motor evoked potentials (MEP), we wanted to compare at baseline (before initiating craniotomy) the stimulation intensity and amplitude of MEP in patients allocated to receive either: propofol, remifentanil (PR group) or propofol,remifentanil,dexmedetomidine(PRD group);Secondary Objective: 1-Propofol and remifentanil requirements 2- Total consumption of propofol and remifentanil 3- Latency and amplitude of somatosensory evoked potentials (SSEP) 4- Mean arterial pressure, heart rate, oxygen saturation (SpO2)and bispectral index (BIS) 5- Time to wake up from anaesthesia 6- Side effects 7- Postoperative analgesics requirements;Primary end point(s): During craniotomy procedures with monitoring of motor evoked potentials (MEP), we wanted to compare at baseline (before initiating craniotomy) the threshold intensity and amplitude of MEP in patients allocated to receive either: propofol, remifentanil (PR group) or propofol,remifentanil,dexmedetomidine(PRD group);Timepoint(s) of evaluation of this end point: At thirty minutes, forty - five minutes and sixty minutes after anaesthetic induction | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Propofol (mg/kg/h) and remifentanil (ug/kg/min) requirements at baseline. 2- Total doses of propofol (mg/kg/h) and remifentanil (ug/kg/min). 3- Latency and amplitude of somatosensory evoked potentials. 4- Mean arterial pressure, heart rate, oxygen saturation by pulse oximetry, bispectral index. 5- Time to wake up. 6- Occurrence of side effects. 7- Postoperative analgesics consumption. ;Timepoint(s) of evaluation of this end point: 1- At baseline (before initiating craniotomy). 2- From anaesthetic induction to the end of surgery. 3- 30, 45, and 60 minutes after anaesthetic induction. 4- Every 5 minutes during anaesthetic induction and surgery. Every 15 minutes in recovery room. 5- From the end of surgery to the verbal response of the patient. 6- During the study. 7- Postoperative 24 h. | — |
Countries
Spain
Contacts
Public ContactServicio de Anestesiología
Parc de Salut Mar
Outcome results
None listed