AnesthesiaPhase 3NeuromorfeoNCT00741351
Anesthesiological Strategies in Elective Craniotomy
A Phase 3 study testing Sevoflurane + Fentanyl, Sevoflurane + Remifentanyl and Propofol + Remifentanyl in people with Anesthesia and Craniotomy, run by Azienda Ospedaliera San Gerardo di Monza at 15 sites in Italy.
Trial summary
This protocol, NeuroMorfeo, aims to assess equivalence between volatile and intravenous anesthetics for neurosurgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Craniotomy, Neurosurgery
- What is being tested?
- Sevoflurane + Fentanyl, Sevoflurane + Remifentanyl and Propofol + Remifentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 15 sitesItaly
- Study dates
- Dec 2007to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for elective intracranial surgery under general anesthesia for a supratentorial mass lesion in the next 24 hours;
- Physical state, evaluated with the ASA (American Society of Anesthesiologists ) classification I (normal healthy patient), II (patient with mild systemic disease), or III (patient with severe systemic disease);
- Age 18-75 years;
- Normal preoperative level of consciousness, i.e. Glasgow Coma Scale (GCS) = 15;
- No signs of intracranial hypertension.
Who cannot join
- Severe cardiovascular pathology, as uncontrolled arterial hypertension, documented reduced coronary reserve.
- Renal or liver disease precluding the use of either anesthetic technique.
- Pregnancy .
- Known allergies to any anesthetic agent.
- Reduced preoperative level of consciousness, i.e.
- Glasgow Coma Scale (GCS) < 15.
Show all 11Show fewer
- Body weight greater than 120 kg.
- History of drug abuse or psychiatric conditions.
- Documented disturbance of the hypothalamic region.Refusal to sign consent form.
- Participation in other clinical trials.
- Delayed awakening, because, due to the location or size of the lesion, postoperative sedation and mechanical ventilation are planned.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Italy15 sites
Policlinico Consorziale di Bari
Bari
Ospedale Bellaria Bologna
Bologna, 40100
IRCCS Fondazione San Raffaele Milano
Milan, 20100
Istituto di Ricerche Farmacologiche Mario Negri - Dipartimento di Ricerca Cardiovascolare-
Milan, 20100
Azienda Ospedaliera San Gerardo
Monza, 20052
Ospedale Maggiore della Carità di Novara
Novara, 28100
Ospedale di Padova
Padua, 35128
Azienda Ospedaliera di Parma
Parma, 43100
Policlinico "A. Gemelli" Roma
Rome
Policlinico "Umberto I" Roma
Rome
Azienda Universitaria Senese
Siena, 53100
Ospedale San Giovanni Bosco Torino
Turin, 10057
Ospedale San giovanni Battista Torino
Turin
Ospedale di Circolo e Fondazione Macchi Varese
Varese, 21100
Azienda Ospedaliera Universitaria di Verona
Verona, 37121
About this study
Official title: Anesthesiological Strategies in Elective Craniotomy: Randomized, Equivalence, Open Trial
This protocol, NeuroMorfeo, aims to assess equivalence between volatile and intravenous anesthetics for neurosurgical procedures.
Read the detailed description
NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for a elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state evaluated with the ASA (I-III) and Glasgow Coma Scale (GCS) equal to 15, will be randomly assigned to one of three anesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanesthesia will be evaluated by comparing the intervals required to reach, after anesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil.
Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anesthesia; intraoperative adverse events (i.e. hypotension, hypertension, requirement of osmotic agents or/and hyperventilation for controlling brain swelling); evaluation of surgical field; postoperative adverse events (as seizures, cough, shivering, agitation, postoperative hematoma and postoperative pain); patient's satisfaction and an analysis of costs.
411 patients will be recruited in 14 different Italian centers during an 18-month period.
The recruitment started December 20th, 2007 and up to 11th March 2009.
- Conditions
- Anesthesia, Craniotomy, Neurosurgery
- Being tested
- Sevoflurane + Fentanyl, Sevoflurane + Remifentanyl, Propofol + Remifentanyl
- Keywords
- Anesthesia, Craniotomy, Neurosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane + FentanylDrug
Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and fentanyl (2-3 microg/kg/hr or 0.7 microg/kg boluses). Just before incision of the scalp, fentanyl (1-2microg/kg/hr) can be supplemented, if necessary
Sevoflurane + RemifentanylDrug
Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and remifentanil (0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening). Just before incision of the scalp, remifentanil can be supplemented, if necessary
Propofol + RemifentanylDrug
Propofol is maintained with continuous infusion at 10 mg/kg/h for the first 10 minutes, then reduced to 8 mg/kg/h for the following 10 minutes and reduced to 6mg/kg/h thereafter and remifentanil 0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening. Just before incision of the scalp, remifentanil could be supplemented, if necessary
| Study group | Role | What they receive |
|---|---|---|
| IF | Experimental | Sevoflurane (Inhalation)+Fentanyl Receives: Drug: Sevoflurane + Fentanyl |
| IR | Experimental | Sevoflurane (Inhalation)+Remifentanyl Receives: Drug: Sevoflurane + Remifentanyl |
| ER | Experimental | Propofol (Endovenous)+ Remifentanyl Receives: Drug: Propofol + Remifentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-anesthesia awaking time, assessed as the interval (min:sec)required to reach an ALDRETE score ≥ 9
Measured: From estubation to aldrete score ≥ 9
Secondary outcomes (5)
Neurovegetative stress
Measured: From induction of anesthesia to 24 hours after surgery
Intraoperative and post-operative adverse events assessment
Measured: From induction of anesthesia to 24 hours after surgery
Brain relaxation evaluated by a blinded neurosurgeon
Measured: From induction of anesthesia to 24 hours after surgery
Patient's satisfaction
Measured: From induction of anesthesia to 24 hours after surgery
Costs of the three strategies
Measured: From induction of anesthesia to end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Gerardo di Monza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dott. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza
- Investigators
- Giuseppe Citerio, MD, Principal investigator, Azienda Ospedaliera San Gerardo MonzaAntonio Pesenti, MD, Study chair, Università delgi Studi Milano BicoccaMaria Grazia Franzosi, PhD, Study chair, Istituto Di Ricerche Farmacologiche Mario NegriRoberto Latini, MD, Study chair, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741351
- Sponsor's protocol ID
- EudraCT number 2007-005279-32
- Other IDs
- AIFA FARM6FKJKK
- Acronym
- Neuromorfeo
- Status last verified
- Sep 2011
- First submitted
- 22 Aug 2008
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hans P, Bonhomme V. Why we still use intravenous drugs as the basic regimen for neurosurgical anaesthesia. Curr Opin Anaesthesiol. 2006 Oct;19(5):498-503. doi: 10.1097/01.aco.0000245274.69292.ad.
PubMed 16960481Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002.
PubMed 8512094Engelhard K, Werner C. Inhalational or intravenous anesthetics for craniotomies? Pro inhalational. Curr Opin Anaesthesiol. 2006 Oct;19(5):504-8. doi: 10.1097/01.aco.0000245275.76916.87.
PubMed 16960482Magni G, Baisi F, La Rosa I, Imperiale C, Fabbrini V, Pennacchiotti ML, Rosa G. No difference in emergence time and early cognitive function between sevoflurane-fentanyl and propofol-remifentanil in patients undergoing craniotomy for supratentorial intracranial surgery. J Neurosurg Anesthesiol. 2005 Jul;17(3):134-8. doi: 10.1097/01.ana.0000167447.33969.16.
PubMed 16037733Talke P, Caldwell JE, Brown R, Dodson B, Howley J, Richardson CA. A comparison of three anesthetic techniques in patients undergoing craniotomy for supratentorial intracranial surgery. Anesth Analg. 2002 Aug;95(2):430-5, table of contents. doi: 10.1097/00000539-200208000-00036.
PubMed 12145066Gomberg-Maitland M, Frison L, Halperin JL. Active-control clinical trials to establish equivalence or noninferiority: methodological and statistical concepts linked to quality. Am Heart J. 2003 Sep;146(3):398-403. doi: 10.1016/S0002-8703(03)00324-7.
PubMed 12947355Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995 Feb;7(1):89-91. doi: 10.1016/0952-8180(94)00001-k. No abstract available.
PubMed 7772368Balakrishnan G, Raudzens P, Samra SK, Song K, Boening JA, Bosek V, Jamerson BD, Warner DS. A comparison of remifentanil and fentanyl in patients undergoing surgery for intracranial mass lesions. Anesth Analg. 2000 Jul;91(1):163-9. doi: 10.1097/00000539-200007000-00030.
PubMed 10866905Del Gaudio A, Ciritella P, Perrotta F, Puopolo M, Lauta E, Mastronardi P, De Vivo P. Remifentanil vs fentanyl with a target controlled propofol infusion in patients undergoing craniotomy for supratentorial lesions. Minerva Anestesiol. 2006 May;72(5):309-19. English, Italian.
PubMed 16675939Klingstedt C, Giesecke K, Hamberger B, Jarnberg PO. High- and low-dose fentanyl anaesthesia: circulatory and plasma catecholamine responses during cholecystectomy. Br J Anaesth. 1987 Feb;59(2):184-8. doi: 10.1093/bja/59.2.184.
PubMed 3828169Nishiyama T, Yamashita K, Yokoyama T. Stress hormone changes in general anesthesia of long duration: isoflurane-nitrous oxide vs sevoflurane-nitrous oxide anesthesia. J Clin Anesth. 2005 Dec;17(8):586-91. doi: 10.1016/j.jclinane.2005.03.009.
PubMed 16427527Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
PubMed 10927999Bent JM, Paterson JL, Mashiter K, Hall GM. Effects of high-dose fentanyl anaesthesia on the established metabolic and endocrine response to surgery. Anaesthesia. 1984 Jan;39(1):19-23. doi: 10.1111/j.1365-2044.1984.tb09447.x.
PubMed 6696213Heesen M, Deinsberger W, Dietrich GV, Detsch O, Boldt J, Hempelmann G. Increase of interleukin-6 plasma levels after elective craniotomy: influence of interleukin-10 and catecholamines. Acta Neurochir (Wien). 1996;138(1):77-80. doi: 10.1007/BF01411728.
PubMed 8686529Ledowski T, Bein B, Hanss R, Paris A, Fudickar W, Scholz J, Tonner PH. Neuroendocrine stress response and heart rate variability: a comparison of total intravenous versus balanced anesthesia. Anesth Analg. 2005 Dec;101(6):1700-1705. doi: 10.1213/01.ane.0000184041.32175.14.
PubMed 16301244
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesiological Strategies in Elective Craniotomy: Randomized, Equivalence, Open Trial
- ClinicalTrials.gov ID
- NCT00741351
- Acronym / sponsor ID
- Neuromorfeo / EudraCT number 2007-005279-32
- Conditions
- Anesthesia, Craniotomy, Neurosurgery
- Keywords
- Anesthesia, Craniotomy, Neurosurgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Gerardo di MonzaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol, NeuroMorfeo, aims to assess equivalence between volatile and intravenous anesthetics for neurosurgical procedures.
Detailed description
NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for a elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state evaluated with the ASA (I-III) and Glasgow Coma Scale (GCS) equal to 15, will be randomly assigned to one of three anesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanesthesia will be evaluated by comparing the intervals required to reach, after anesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil.
Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anesthesia; intraoperative adverse events (i.e. hypotension, hypertension, requirement of osmotic agents or/and hyperventilation for controlling brain swelling); evaluation of surgical field; postoperative adverse events (as seizures, cough, shivering, agitation, postoperative hematoma and postoperative pain); patient's satisfaction and an analysis of costs.
411 patients will be recruited in 14 different Italian centers during an 18-month period.
The recruitment started December 20th, 2007 and up to 11th March 2009.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IF | Experimental | Drug: Sevoflurane + FentanylSevoflurane (Inhalation)+Fentanyl |
| IR | Experimental | Drug: Sevoflurane + RemifentanylSevoflurane (Inhalation)+Remifentanyl |
| ER | Experimental | Drug: Propofol + RemifentanylPropofol (Endovenous)+ Remifentanyl |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient scheduled for elective intracranial surgery under general anesthesia for a supratentorial mass lesion in the next 24 hours;
- Physical state, evaluated with the ASA (American Society of Anesthesiologists ) classification I (normal healthy patient), II (patient with mild systemic disease), or III (patient with severe systemic disease);
- Age 18-75 years;
- Normal preoperative level of consciousness, i.e. Glasgow Coma Scale (GCS) = 15;
- No signs of intracranial hypertension.
Key exclusion criteria (11 listed)
- Severe cardiovascular pathology, as uncontrolled arterial hypertension, documented reduced coronary reserve.
- Renal or liver disease precluding the use of either anesthetic technique.
- Pregnancy .
- Known allergies to any anesthetic agent.
- Reduced preoperative level of consciousness, i.e.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane + FentanylSevoflurane is maintained in a MAC range (0.75% to 1.25%) and fentanyl (2-3 microg/kg/hr or 0.7 microg/kg boluses). Just before incision of the scalp, fentanyl (1-2microg/kg/hr) can be supplemented, if necessary | Drug | IF |
| Sevoflurane + RemifentanylSevoflurane is maintained in a MAC range (0.75% to 1.25%) and remifentanil (0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening). Just before incision of the scalp, remifentanil can be supplemented, if necessary | Drug | IR |
| Propofol + RemifentanylPropofol is maintained with continuous infusion at 10 mg/kg/h for the first 10 minutes, then reduced to 8 mg/kg/h for the following 10 minutes and reduced to 6mg/kg/h thereafter and remifentanil 0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening. Just before incision of the scalp, remifentanil could be supplemented, if necessary | Drug | ER |
Primary outcome
Post-anesthesia awaking time, assessed as the interval (min:sec)required to reach an ALDRETE score ≥ 9
Time frame: From estubation to aldrete score ≥ 9
5 secondary outcomes
Neurovegetative stress
Time frame: From induction of anesthesia to 24 hours after surgery
Intraoperative and post-operative adverse events assessment
Time frame: From induction of anesthesia to 24 hours after surgery
Brain relaxation evaluated by a blinded neurosurgeon
Time frame: From induction of anesthesia to 24 hours after surgery
Patient's satisfaction
Time frame: From induction of anesthesia to 24 hours after surgery
Costs of the three strategies
Time frame: From induction of anesthesia to end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
- Background: PubMed 16960481Hans P, Bonhomme V. Why we still use intravenous drugs as the basic regimen for neurosurgical anaesthesia. Curr Opin Anaesthesiol. 2006 Oct;19(5):498-503. doi: 10.1097/01.aco.0000245274.69292.ad.
- Background: PubMed 8512094Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002.
- Background: PubMed 16960482Engelhard K, Werner C. Inhalational or intravenous anesthetics for craniotomies? Pro inhalational. Curr Opin Anaesthesiol. 2006 Oct;19(5):504-8. doi: 10.1097/01.aco.0000245275.76916.87.
- Background: PubMed 16037733Magni G, Baisi F, La Rosa I, Imperiale C, Fabbrini V, Pennacchiotti ML, Rosa G. No difference in emergence time and early cognitive function between sevoflurane-fentanyl and propofol-remifentanil in patients undergoing craniotomy for supratentorial intracranial surgery. J Neurosurg Anesthesiol. 2005 Jul;17(3):134-8. doi: 10.1097/01.ana.0000167447.33969.16.
- Background: PubMed 12145066Talke P, Caldwell JE, Brown R, Dodson B, Howley J, Richardson CA. A comparison of three anesthetic techniques in patients undergoing craniotomy for supratentorial intracranial surgery. Anesth Analg. 2002 Aug;95(2):430-5, table of contents. doi: 10.1097/00000539-200208000-00036.
- Background: PubMed 12947355Gomberg-Maitland M, Frison L, Halperin JL. Active-control clinical trials to establish equivalence or noninferiority: methodological and statistical concepts linked to quality. Am Heart J. 2003 Sep;146(3):398-403. doi: 10.1016/S0002-8703(03)00324-7.
- Background: PubMed 7772368Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995 Feb;7(1):89-91. doi: 10.1016/0952-8180(94)00001-k. No abstract available.
- Background: PubMed 10866905Balakrishnan G, Raudzens P, Samra SK, Song K, Boening JA, Bosek V, Jamerson BD, Warner DS. A comparison of remifentanil and fentanyl in patients undergoing surgery for intracranial mass lesions. Anesth Analg. 2000 Jul;91(1):163-9. doi: 10.1097/00000539-200007000-00030.
- Background: PubMed 16675939Del Gaudio A, Ciritella P, Perrotta F, Puopolo M, Lauta E, Mastronardi P, De Vivo P. Remifentanil vs fentanyl with a target controlled propofol infusion in patients undergoing craniotomy for supratentorial lesions. Minerva Anestesiol. 2006 May;72(5):309-19. English, Italian.
- Background: PubMed 3828169Klingstedt C, Giesecke K, Hamberger B, Jarnberg PO. High- and low-dose fentanyl anaesthesia: circulatory and plasma catecholamine responses during cholecystectomy. Br J Anaesth. 1987 Feb;59(2):184-8. doi: 10.1093/bja/59.2.184.
- Background: PubMed 16427527Nishiyama T, Yamashita K, Yokoyama T. Stress hormone changes in general anesthesia of long duration: isoflurane-nitrous oxide vs sevoflurane-nitrous oxide anesthesia. J Clin Anesth. 2005 Dec;17(8):586-91. doi: 10.1016/j.jclinane.2005.03.009.
- Background: PubMed 10927999Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
Related trials for Anesthesia
Recruiting
Lateral QL Block vs Intrathecal Morphine for Cesarean Section
Anesthesia, Postoperative Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Citerio, MD principal investigator
Azienda Ospedaliera San Gerardo Monza
Antonio Pesenti, MD study chair
Università delgi Studi Milano Bicocca
Maria Grazia Franzosi, PhD study chair
Istituto Di Ricerche Farmacologiche Mario Negri
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevoflurane + Fentanyl, Sevoflurane + Remifentanyl and Propofol + Remifentanyl in people with Anesthesia and Craniotomy, run by Azienda Ospedaliera San Gerardo di Monza at 15 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-anesthesia awaking time, assessed as the interval (min:sec)required to reach an ALDRETE score ≥ 9 (time frame: From estubation to aldrete score ≥ 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00741351, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2011; AzTrials last refreshed its copy on 31 Oct 2026.