CoughPhase 4REMEXNCT02711904
Concentrations of Remifentanil for Extubation
A Phase 4 study testing Extubation U and Extubation T in people with Cough, run by Seganest at 1 site in Colombia.
Trial summary
Condition of the State: (terminated, recruiting, etc.) Terminated Study Design: Main Objective: Compare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cough
- What is being tested?
- Extubation U and Extubation T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2011to Jul 2012
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged 18-70 years
- Risk Scale American Society of Anaesthesiologists physical status classification (ASA) I and II
- Undergoing elective ear surgery
Who cannot join
- Patients who are contraindicated remifentanil
- Patients undergoing emergency surgery
- Pulmonary Pathology (ASTHMA - COPD)
- Index of body mass greater than 35
- Background of respiratory failure three weeks prior to the procedure
- Smokers
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Instituto Para Niños Ciegos y Sordos del Valle del Cauca
Cali, Valle del Cauca Department, 288 00
About this study
Official title: Effect of Two Plasma Concentrations of Remifentanil Through Target Controlled Anesthesia on Frequency and Intensity of Coughing During Extubation: Randomized Controlled Clinical Trial
Condition of the State: (terminated, recruiting, etc.) Terminated
Study Design: Main Objective:
Compare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled anesthesia
Read the detailed description
Phase of the study:
Phase IV
Intervention:
Drug: U Extubation
Other Names:
Concentration 2 - 3 ng/ml Dose of remifentanil according to the randomization: Letter U between 2 - 3 ng/ml. The infusions that were used to reach the (PC) target were: Group U = 2 - 3 ng/ml. 20 years old - 6.0 mcg/Kg/h, 30 years old - 5.7 mcg/Kg/h, 40 years old - 5.3 mcg/kg/h, 50 years old - 5.0 mcg/kg/h, 60 years old - 4.6 mcg/kg/h, 70 years old - 4.3 mcg/kg/h, 80 years old - 4.0 mcg kg/h.
Drug: Extubation T
Other Names:
Concentration 3 - 4 ng/ml Dose of infusion of remifentanil to reach a (PC) 3 - 4 ng/ml, in the following manner: The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient. The remifentanil dose was adjusted according to the randomization: Group T = 3 - 4 ng/ml. 20 years old - 9.0 mcg/Kg/h, 30 years old - 8.5 mcg/Kg/h, 40 years old - 8.0 mcg/kg/h, 50 years old - 7.5 mcg/kg/h, 60 years old - 7.0 mcg/kg/h, 70 years old - 6.5 mcg/kg/h, 80 years old - 6.0 mcg kg/h.
Number of arms:
2
Masking:
The patient had masking with regards to the anesthetic procedure from the unfamiliarity per se of the same and by agents used in this that induced anxiolysis and hypnosis.
To guarantee the masking to the viewer, which was the treating anesthesiologist, a nurse was trained in the adjustment of the infusion balloon. Ten minutes before concluding the procedure and by request of the anesthesiologist, the nurse proceeded to locate balloon in such a way that the infusion could not be seen by the anesthesiologist, then opened the envelope and adjusted the infusion according to the randomization (U) o (T). The evaluation of the cough, its intensity and the Ramsay were under the care of the anesthesiologist, who was unaware of the awakening infusion.
Allocation:
Two were allocated for the use: Concentration of remifentanil of 2 - 3 ng/ml (group U) and concentration of remifentanil of 3 - 4 ng/ml (group T).
Recruitment:
A patient was recruited between the period of January 2011 and July 2012.
- Conditions
- Cough
- Being tested
- Extubation U, Extubation T
- Keywords
- Extubation, Cough, Target Controlled Anesthesia (TACAN)
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extubation UDrug
Also called Ultiva
Dose of remifentanil according to the randomization; the infusions that were used to reach the PC target were:
- 20 years old - 6.0 mcg/Kg/h
- 30 years old - 5.7 mcg/Kg/h
- 40 years old - 5.3 mcg/kg/h
- 50 years old - 5.0 mcg/kg/h
- 60 years old - 4.6 mcg/kg/h
- 70 years old - 4.3 mcg/kg/h
- 80 years old - 4.0 mcg kg/h.
Extubation TDrug
Also called Ultiva
Dose of infusion of remifentanil to reach a PC 3 - 4 ng/ml, in the following manner:
The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient.
The remifentanil dose was adjusted according to the randomization:
- 20 years old - 9.0 mcg/Kg/h
- 30 years old - 8.5 mcg/Kg/h
- 40 years old - 8.0 mcg/kg/h
- 50 years old - 7.5 mcg/kg/h
- 60 years old - 7.0 mcg/kg/h
- 70 years old - 6.5 mcg/kg/h
- 80 years old - 6.0 mcg kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Extubation U | Active comparator | Remifentanil concentration between 2 - 3 ng/ml. Receives: Drug: Extubation U |
| Extubation T | Experimental | Remifentanil concentration between 3 - 4 ng/ml Receives: Drug: Extubation T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough
Number of episodes and duration of cough that occur when the patient responds to verbal stimulus and extubated.
Cough Scale
- Grade 0 = No cough
- Grade 1 = Mild (only episode of cough)
- Grade 2 = Moderate (more than 1episode of cough during less than 5 seconds)
- Grade 3 = Severe (More than one episode of cough that lasted more than 5 seconds or purposeless movements of the extremities).
Measured: It is evaluated by the scale of cough over a two hour period after surgery: is assessed at 5 minutes turned off the halogenated inhalation anesthetics, thereafter every minute until the patient responds to verbal stimulus and can be extubated
Secondary outcomes (2)
Wake time.
When vaporizer where closed until the patient responds to the verbal stimulus and is extubated.
Defined as the time taken to open eyes after having turned off the halogenated inhalation anesthetics.
Measured: During two hours after surgery, five minutes after turning off halogenated inhaled anesthetics, then every minute until the patient opens his eyes and is extubated.
Ramsay scale at the time of extubation
Ramsay scale: score objective system for measuring drug-induced sedation
- Score 1: Anxious or restless or both
- Score 2: Cooperative, orientated and tranquil
- Score 3: Responding to commands
- Score 4: Brisk response to stimulus
- Score 5: Sluggish response to stimulus
- Score 6: No response to stimulus
Measured: During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJan 2011
- Primary completionJan 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for CoughStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seganest
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Para Ninos Ciegos y Sordos del Valle del Cauca
- Responsible party
- Principal investigator, LUIS ALBERTO TAFUR B, Seganest
- Investigators
- LUIS A TAFUR, MD, Principal investigator, SeganestEduardo Lema, MD, Study director, Seganest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711904
- Sponsor's protocol ID
- SEGANEST
- Acronym
- REMEX
- Status last verified
- Mar 2016
- First submitted
- 27 Aug 2013
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The individual data of the participants (IPD) were only available to the ethics committee of the institution.
Publications
Neelakanta G, Miller J. Minimum alveolar concentration of isoflurane for tracheal extubation in deeply anesthetized children. Anesthesiology. 1994 Apr;80(4):811-3. doi: 10.1097/00000542-199404000-00013.
PubMed 8024135Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x.
PubMed 16095449Saghaei M, Reisinejad A, Soltani H. Prophylactic versus therapeutic administration of intravenous lidocaine for suppression of post-extubation cough following cataract surgery: a randomized double blind placebo controlled clinical trial. Acta Anaesthesiol Taiwan. 2005 Dec;43(4):205-9.
PubMed 16450594Minogue SC, Ralph J, Lampa MJ. Laryngotracheal topicalization with lidocaine before intubation decreases the incidence of coughing on emergence from general anesthesia. Anesth Analg. 2004 Oct;99(4):1253-1257. doi: 10.1213/01.ANE.0000132779.27085.52.
PubMed 15385385Fagan C, Frizelle HP, Laffey J, Hannon V, Carey M. The effects of intracuff lidocaine on endotracheal-tube-induced emergence phenomena after general anesthesia. Anesth Analg. 2000 Jul;91(1):201-5. doi: 10.1097/00000539-200007000-00038.
PubMed 10866913Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. doi: 10.1097/00000542-199806000-00007.
PubMed 9637637Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9. doi: 10.1111/j.1399-6576.1995.tb05597.x.
PubMed 7725888Mendel P, Fredman B, White PF. Alfentanil suppresses coughing and agitation during emergence from isoflurane anesthesia. J Clin Anesth. 1995 Mar;7(2):114-8. doi: 10.1016/0952-8180(94)00024-x.
PubMed 7598918Sant'Ambrogio G, Widdicombe J. Reflexes from airway rapidly adapting receptors. Respir Physiol. 2001 Mar;125(1-2):33-45. doi: 10.1016/s0034-5687(00)00203-6.
PubMed 11240151Lema FE, Tafur LA, Giraldo C, Delgado MA. [Incidence of cough after desflurane and sevoflurane administration through a laryngeal mask: a controlled clinical trial]. Rev Esp Anestesiol Reanim. 2010 Mar;57(3):141-6. doi: 10.1016/s0034-9356(10)70188-2. Spanish.
PubMed 20422846Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PubMed 4835444Grahame-Smith DG. How will knowledge of the human genome affect drug therapy? Br J Clin Pharmacol. 1999 Jan;47(1):7-10. doi: 10.1046/j.1365-2125.1999.00909.x. No abstract available.
PubMed 10073732Van Poucke GE, Bravo LJ, Shafer SL. Target controlled infusions: targeting the effect site while limiting peak plasma concentration. IEEE Trans Biomed Eng. 2004 Nov;51(11):1869-75. doi: 10.1109/TBME.2004.827935.
PubMed 15536889Tafur LA, Gómez JM, Parra LE. Validación de nomogramas de remifentanil y propofol para la administración de anestesia total endovenosa. Rev. Col. Anest. 2009; 37:21-8.
Mertens MJ, Olofsen E, Engbers FH, Burm AG, Bovill JG, Vuyk J. Propofol reduces perioperative remifentanil requirements in a synergistic manner: response surface modeling of perioperative remifentanil-propofol interactions. Anesthesiology. 2003 Aug;99(2):347-59. doi: 10.1097/00000542-200308000-00016.
PubMed 12883407
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Plasma Concentrations of Remifentanil Through Target Controlled Anesthesia on Frequency and Intensity of Coughing During Extubation: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02711904
- Acronym / sponsor ID
- REMEX / SEGANEST
- Conditions
- Cough
- Keywords
- Extubation, Cough, Target Controlled Anesthesia (TACAN)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SeganestUniversity, hospital or other
- Collaborators
- Instituto Para Ninos Ciegos y Sordos del Valle del Cauca
- Study start
- Jan 2011
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 Mar 2016 (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.
Condition of the State: (terminated, recruiting, etc.) Terminated
Study Design: Main Objective:
Compare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled anesthesia
Detailed description
Phase of the study:
Phase IV
Intervention:
Drug: U Extubation
Other Names:
Concentration 2 - 3 ng/ml Dose of remifentanil according to the randomization: Letter U between 2 - 3 ng/ml. The infusions that were used to reach the (PC) target were: Group U = 2 - 3 ng/ml. 20 years old - 6.0 mcg/Kg/h, 30 years old - 5.7 mcg/Kg/h, 40 years old - 5.3 mcg/kg/h, 50 years old - 5.0 mcg/kg/h, 60 years old - 4.6 mcg/kg/h, 70 years old - 4.3 mcg/kg/h, 80 years old - 4.0 mcg kg/h.
Drug: Extubation T
Other Names:
Concentration 3 - 4 ng/ml Dose of infusion of remifentanil to reach a (PC) 3 - 4 ng/ml, in the following manner: The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient. The remifentanil dose was adjusted according to the randomization: Group T = 3 - 4 ng/ml. 20 years old - 9.0 mcg/Kg/h, 30 years old - 8.5 mcg/Kg/h, 40 years old - 8.0 mcg/kg/h, 50 years old - 7.5 mcg/kg/h, 60 years old - 7.0 mcg/kg/h, 70 years old - 6.5 mcg/kg/h, 80 years old - 6.0 mcg kg/h.
Number of arms:
2
Masking:
The patient had masking with regards to the anesthetic procedure from the unfamiliarity per se of the same and by agents used in this that induced anxiolysis and hypnosis.
To guarantee the masking to the viewer, which was the treating anesthesiologist, a nurse was trained in the adjustment of the infusion balloon. Ten minutes before concluding the procedure and by request of the anesthesiologist, the nurse proceeded to locate balloon in such a way that the infusion could not be seen by the anesthesiologist, then opened the envelope and adjusted the infusion according to the randomization (U) o (T). The evaluation of the cough, its intensity and the Ramsay were under the care of the anesthesiologist, who was unaware of the awakening infusion.
Allocation:
Two were allocated for the use: Concentration of remifentanil of 2 - 3 ng/ml (group U) and concentration of remifentanil of 3 - 4 ng/ml (group T).
Recruitment:
A patient was recruited between the period of January 2011 and July 2012.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation U | Active comparator | Drug: Extubation URemifentanil concentration between 2 - 3 ng/ml. |
| Extubation T | Experimental | Drug: Extubation TRemifentanil concentration between 3 - 4 ng/ml |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients aged 18-70 years
- Risk Scale American Society of Anaesthesiologists physical status classification (ASA) I and II
- Undergoing elective ear surgery
Key exclusion criteria (6 listed)
- Patients who are contraindicated remifentanil
- Patients undergoing emergency surgery
- Pulmonary Pathology (ASTHMA - COPD)
- Index of body mass greater than 35
- Background of respiratory failure three weeks prior to the procedure
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 |
|---|---|---|
| Extubation UAlso: UltivaDose of remifentanil according to the randomization; the infusions that were used to reach the PC target were: * 20 years old - 6.0 mcg/Kg/h * 30 years old - 5.7 mcg/Kg/h * 40 years old - 5.3 mcg/kg/h * 50 years old - 5.0 mcg/kg/h * 60 years old - 4.6 mcg/kg/h * 70 years old - 4.3 mcg/kg/h * 80 years old - 4.0 mcg kg/h. | Drug | Extubation U |
| Extubation TAlso: UltivaDose of infusion of remifentanil to reach a PC 3 - 4 ng/ml, in the following manner: The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient. The remifentanil dose was adjusted according to the randomization: * 20 years old - 9.0 mcg/Kg/h * 30 years old - 8.5 mcg/Kg/h * 40 years old - 8.0 mcg/kg/h * 50 years old - 7.5 mcg/kg/h * 60 years old - 7.0 mcg/kg/h * 70 years old - 6.5 mcg/kg/h * 80 years old - 6.0 mcg kg/h. | Drug | Extubation T |
Primary outcome
Cough
Time frame: It is evaluated by the scale of cough over a two hour period after surgery: is assessed at 5 minutes turned off the halogenated inhalation anesthetics, thereafter every minute until the patient responds to verbal stimulus and can be extubated
Number of episodes and duration of cough that occur when the patient responds to verbal stimulus and extubated. Cough Scale * Grade 0 = No cough * Grade 1 = Mild (only episode of cough) * Grade 2 = Moderate (more than 1episode of cough during less than 5 seconds) * Grade 3 = Severe (More than one episode of cough that lasted more than 5 seconds or purposeless movements of the extremities).
2 secondary outcomes
Wake time.
Time frame: During two hours after surgery, five minutes after turning off halogenated inhaled anesthetics, then every minute until the patient opens his eyes and is extubated.
Ramsay scale at the time of extubation
Time frame: During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered
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 17 Mar 2016.
- Background: PubMed 8024135Neelakanta G, Miller J. Minimum alveolar concentration of isoflurane for tracheal extubation in deeply anesthetized children. Anesthesiology. 1994 Apr;80(4):811-3. doi: 10.1097/00000542-199404000-00013.
- Background: PubMed 16095449Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x.
- Background: PubMed 16450594Saghaei M, Reisinejad A, Soltani H. Prophylactic versus therapeutic administration of intravenous lidocaine for suppression of post-extubation cough following cataract surgery: a randomized double blind placebo controlled clinical trial. Acta Anaesthesiol Taiwan. 2005 Dec;43(4):205-9.
- Background: PubMed 15385385Minogue SC, Ralph J, Lampa MJ. Laryngotracheal topicalization with lidocaine before intubation decreases the incidence of coughing on emergence from general anesthesia. Anesth Analg. 2004 Oct;99(4):1253-1257. doi: 10.1213/01.ANE.0000132779.27085.52.
- Background: PubMed 10866913Fagan C, Frizelle HP, Laffey J, Hannon V, Carey M. The effects of intracuff lidocaine on endotracheal-tube-induced emergence phenomena after general anesthesia. Anesth Analg. 2000 Jul;91(1):201-5. doi: 10.1097/00000539-200007000-00038.
- Background: PubMed 9637637Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. doi: 10.1097/00000542-199806000-00007.
- Background: PubMed 7725888Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9. doi: 10.1111/j.1399-6576.1995.tb05597.x.
- Background: PubMed 7598918Mendel P, Fredman B, White PF. Alfentanil suppresses coughing and agitation during emergence from isoflurane anesthesia. J Clin Anesth. 1995 Mar;7(2):114-8. doi: 10.1016/0952-8180(94)00024-x.
- Background: PubMed 11240151Sant'Ambrogio G, Widdicombe J. Reflexes from airway rapidly adapting receptors. Respir Physiol. 2001 Mar;125(1-2):33-45. doi: 10.1016/s0034-5687(00)00203-6.
- Background: PubMed 20422846Lema FE, Tafur LA, Giraldo C, Delgado MA. [Incidence of cough after desflurane and sevoflurane administration through a laryngeal mask: a controlled clinical trial]. Rev Esp Anestesiol Reanim. 2010 Mar;57(3):141-6. doi: 10.1016/s0034-9356(10)70188-2. Spanish.
- Background: PubMed 4835444Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
- Background: PubMed 10073732Grahame-Smith DG. How will knowledge of the human genome affect drug therapy? Br J Clin Pharmacol. 1999 Jan;47(1):7-10. doi: 10.1046/j.1365-2125.1999.00909.x. No abstract available.
- Individual participant dataSharing planned: No. The individual data of the participants (IPD) were only available to the ethics committee of the institution.
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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.
LUIS A TAFUR, MD principal investigator
Seganest
Eduardo Lema, MD study director
Seganest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Extubation U and Extubation T in people with Cough, run by Seganest at 1 site in Colombia.
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 3 inclusion and 6 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Cough (time frame: It is evaluated by the scale of cough over a two hour period after surgery: is assessed at 5 minutes turned off the halogenated inhalation anesthetics, thereafter every minute until the patient responds to verbal stimulus and can be extubated). 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 NCT02711904, which also lists 33 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 17 Mar 2016.