Coronary Artery DiseasePhase 4NCT04223219
Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University
A Phase 4 study testing Fentanyl, Fentanyl, Propofol and Dexmedetomidine, Ketamine, Magnesium sulfate in people with Coronary Artery Disease and Valve Disease, Heart, run by Mansoura University at 1 site in Egypt.
Trial summary
Cardiac surgery is associated with post-operative pain which is one of the major problems and remains one of the most controversial issues. Inadequate pain control after cardiac surgery increases the incidence of development of many complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Valve Disease, Heart, Pain, Acute
- What is being tested?
- Fentanyl, Fentanyl, Propofol and Dexmedetomidine, Ketamine, Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2019to 15 Sep 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients of both gender,
- Aged above 18 years
- American Society of Anesthesiologists (ASA) physical status II \& III,
- Body mass index less than 40 kg/m2
- Scheduled for any cardiac procedure with median sternotomy that require cardiopulmonary bypass at Cardiothoracic Surgical Department, Mansoura University Hospitals.
Who cannot join
- Patients with pulmonary dysfunction or chronic obstructive pulmonary diseases
- Acute or unstable angina
- Previous cardio-thoracic surgery
- Emergency surgery
- Left ventricular ejection fraction less than 40%
- Dysrhythmia or pacemaker
Show all 10Show fewer
- Major hepatic or renal dysfunction
- Need for re-exploration, uncontrolled diabetes (HbA1c > 8.5)
- Neurological deficit
- Hyper-magnesemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University: Randomized Prospective Comparative Study
Cardiac surgery is associated with post-operative pain which is one of the major problems and remains one of the most controversial issues. Inadequate pain control after cardiac surgery increases the incidence of development of many complications. Intravenous opioids are commonly used for postoperative analgesia either on demand "physician or nurse-controlled" or patient -controlled.
Multimodal opioid sparing analgesia has become frequently used, These techniques can be achieved with Dexmedetomidine, low-dose ketamine and magnesium.
The study hypotheses that control of perioperative quality of pain with opioid sparing medications may improve analgesia and patient outcome.
Read the detailed description
Pain after cardiac surgery is triggered by numerous factors including skin incision, sternotomy, sternal and rib retraction, internal mammary artery and saphenous vein harvesting, surgical manipulation of pleura, placement of chest tubes and tissue trauma during surgery.Median sternotomy significantly reduces postoperative pulmonary function; however, it is the most commonly used approach because it facilitates exposure of the surgical field.
Pain prevents early mobilization, reduction in pulmonary function and accumulation of bronchial secretions resulting in atelectasis, pulmonary infections, hypoxia and increase duration of ICU stay.Prolonged ICU stay is associated with greater risk of respiratory and renal dysfunction, and increases morbidity and mortality.
Optimal post-operative pain management allows early weaning from mechanical ventilation and extubation, early mobilization, facilitate beginning of chest physiotherapy, shortens the length of ICU stay and hospitalization, medical costs and decreases incidence of post-operative complications.
Opioid infusions and patient-controlled analgesia (PCA) remain the principal and most commonly used for immediate postoperative analgesia after cardiac surgery in Intensive Care Units.
Multimodal opioid sparing analgesia has become frequently used. They are used for the opioids sparing effect and for achievement of a more efficient pain management via both central and peripheral anti-nociceptive mechanisms.
Dexmedetomidine is an intravenous α-2 agonist widely used for sedation, anxiolysis and for augmenting anesthesia and analgesia with reduction in opioid requirements. Ketamine have a great analgesic effect and can be added to multimodal regimen. Magnesium can be added to multimodal regimen as it acts as a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptors and has anti-inflammatory effects and can be used in acute pain management.
The aim of this study is to compare between traditional high opioid, low opioid and non-opioid technique on the patient outcome.
This prospective randomized comparative study will be conducted on 75 patients undergoing cardiac procedures that will require cardiopulmonary bypass and median sternotomy at Cardiothoracic Surgical Department, Mansoura University Hospitals over 24 months.
Eligible 90 patients will be randomly allocated to one of three equal groups each contains 25 patients, they will be randomized according to computer-generated randomization sequence: Either high opioid group (group I), Low opioid group (group II) and non-opioid group (group III).
- Being tested
- Fentanyl, Fentanyl, Propofol, Dexmedetomidine, Ketamine, Magnesium sulfate
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases, Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
- Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg.
- Maintenance of anesthesia (intraoperative until tracheal extubation):
Maintenance will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxygen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min.
- The patients will receive fentanyl infusion at a rate of 1 µg/kg/h and fentanyl bolus 20-40 µg according to patient hemodynamics. (tachycardia: increase of heart rate >20% of baseline or hypertension: increase of blood pressure >20% of baseline).
- After tracheal extubation: all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion.
Fentanyl, PropofolDrug
- Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg.
- Maintenance of anesthesia (intraoperative until tracheal extubation):
Maintenance of anesthesia will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxugen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min.
- The patients will receive fentanyl bolus 20 µg/hr and propofol 20 mg at the time of surgical stimulation and according to patient hemodynamics (repeated as required).
- After tracheal extubation: all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion.
Dexmedetomidine, Ketamine, Magnesium sulfateDrug
- Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg.
- Maintenance of anesthesia (intraoperative until tracheal extubation):
Maintenance of anesthesia will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxygen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min.
- The patients will receive infusions of dexmedetomidine 0.2 µg/kg/h, ketamine 2 µg/kg/min, and magnesium sulfate 5 mg/kg/h.
- After tracheal extubation: all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion.
| Study group | Role | What they receive |
|---|---|---|
| High Opioid Group | Active comparator | -The patients will receive fentanyl infusion at a rate of 1 µg/kg/h and fentanyl bolus 20-40 µg according to patient hemodynamics. (tachycardia: increase of heart rate >20% of baseline or hypertension: increase of mean blood pressure >20% of baseline). Receives: Drug: Fentanyl |
| Low Opioid Group | Placebo comparator | The patients will receive fentanyl bolus 20 µg/hr and propofol 20 mg at the time of surgical stimulation and according to patient hemodynamics (repeated as required). Receives: Drug: Fentanyl, Propofol |
| Non-Opioid Group | Experimental | The patients will receive infusions of dexmedetomidine 0.2 µg/kg/h, ketamine 2 µg/kg/min, and magnesium sulfate 5 mg/kg/h. Receives: Drug: Dexmedetomidine, Ketamine, Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score at rest assessed using the visual analogue scale.
visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. orientated from the left (worst) to the right (best) (where 0 is no pain and 100 is the worst pain) lower score means better outcome
Measured: 30 minutes after tracheal extubation
Secondary outcomes (14)
Pain score at rest assessed using the visual analogue scale.
visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. orientated from the left (worst) to the right (best) (where 0 is no pain and 100 is the worst pain) lower score means better outcome
Measured: 2, 6, 12, and 24 hours after tracheal extubation
Sedation level assessed using Ramsay sedation score
Ramsay sedation score used to assess level of sedation range from 1 to 6 where (1: awake, anxious, agitated, restless, 2: awake, cooperative, orientated, and tranquil, 3: responsive to commands only, 4: asleep, brisk response to light glabellar tap or loud auditory stimulus, 5: asleep, sluggish response to light glabellar tap or loud auditory stimulus and, 6: no response to light glabellar tap or loud auditory stimulus).
lower score means better outcome
Measured: 30 minutes, 2, 6, 12, and 24 hours after tracheal extubation
Heart rate
Measured: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Systolic blood pressure
Measured: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Diastolic blood pressure
Measured: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Mean arterial blood pressure
Measured: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Total opioid consumption
calculation of total opioids used intra operative and pos operative
Measured: 24 hours post operative
Time to tracheal extubation
Measured: 2 hours to 6 hours
Duration of ICU stay
Measured: 2 to 5 days
Time to either bowel movement or flatus
Measured: within 24 hours
Number of participants with post-operative nausea and vomiting (PONV)
Measured: within 24 hours
Doses of atropine required
Measured: from start to the end of surgery
Doses of Inotropic required
Measured: from start to the end of surgery
Doses of vasopressors required
Measured: from start to the 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 posted10 Jan 2020
- Study start10 Dec 2019
- Primary completion15 Aug 2021
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Morsy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223219
- Sponsor's protocol ID
- MD.19.11.255
- Status last verified
- Sep 2021
- First submitted
- 28 Dec 2019
- Last updated
- 22 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University: Randomized Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT04223219
- Acronym / sponsor ID
- MD.19.11.255
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 10 Jan 2020 (actual)
- 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.
Cardiac surgery is associated with post-operative pain which is one of the major problems and remains one of the most controversial issues. Inadequate pain control after cardiac surgery increases the incidence of development of many complications. Intravenous opioids are commonly used for postoperative analgesia either on demand "physician or nurse-controlled" or patient -controlled.
Multimodal opioid sparing analgesia has become frequently used, These techniques can be achieved with Dexmedetomidine, low-dose ketamine and magnesium.
The study hypotheses that control of perioperative quality of pain with opioid sparing medications may improve analgesia and patient outcome.
Detailed description
Pain after cardiac surgery is triggered by numerous factors including skin incision, sternotomy, sternal and rib retraction, internal mammary artery and saphenous vein harvesting, surgical manipulation of pleura, placement of chest tubes and tissue trauma during surgery.Median sternotomy significantly reduces postoperative pulmonary function; however, it is the most commonly used approach because it facilitates exposure of the surgical field.
Pain prevents early mobilization, reduction in pulmonary function and accumulation of bronchial secretions resulting in atelectasis, pulmonary infections, hypoxia and increase duration of ICU stay.Prolonged ICU stay is associated with greater risk of respiratory and renal dysfunction, and increases morbidity and mortality.
Optimal post-operative pain management allows early weaning from mechanical ventilation and extubation, early mobilization, facilitate beginning of chest physiotherapy, shortens the length of ICU stay and hospitalization, medical costs and decreases incidence of post-operative complications.
Opioid infusions and patient-controlled analgesia (PCA) remain the principal and most commonly used for immediate postoperative analgesia after cardiac surgery in Intensive Care Units.
Multimodal opioid sparing analgesia has become frequently used. They are used for the opioids sparing effect and for achievement of a more efficient pain management via both central and peripheral anti-nociceptive mechanisms.
Dexmedetomidine is an intravenous α-2 agonist widely used for sedation, anxiolysis and for augmenting anesthesia and analgesia with reduction in opioid requirements. Ketamine have a great analgesic effect and can be added to multimodal regimen. Magnesium can be added to multimodal regimen as it acts as a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptors and has anti-inflammatory effects and can be used in acute pain management.
The aim of this study is to compare between traditional high opioid, low opioid and non-opioid technique on the patient outcome.
This prospective randomized comparative study will be conducted on 75 patients undergoing cardiac procedures that will require cardiopulmonary bypass and median sternotomy at Cardiothoracic Surgical Department, Mansoura University Hospitals over 24 months.
Eligible 90 patients will be randomly allocated to one of three equal groups each contains 25 patients, they will be randomized according to computer-generated randomization sequence: Either high opioid group (group I), Low opioid group (group II) and non-opioid group (group III).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Opioid Group | Active comparator | Drug: Fentanyl-The patients will receive fentanyl infusion at a rate of 1 µg/kg/h and fentanyl bolus 20-40 µg according to patient hemodynamics. (tachycardia: increase of heart rate >20% of baseline or hypertension: increase of mean blood pressure >20% of baseline). |
| Low Opioid Group | Placebo comparator | Drug: Fentanyl, PropofolThe patients will receive fentanyl bolus 20 µg/hr and propofol 20 mg at the time of surgical stimulation and according to patient hemodynamics (repeated as required). |
| Non-Opioid Group | Experimental | Drug: Dexmedetomidine, Ketamine, Magnesium sulfateThe patients will receive infusions of dexmedetomidine 0.2 µg/kg/h, ketamine 2 µg/kg/min, and magnesium sulfate 5 mg/kg/h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients of both gender,
- Aged above 18 years
- American Society of Anesthesiologists (ASA) physical status II \& III,
- Body mass index less than 40 kg/m2
- Scheduled for any cardiac procedure with median sternotomy that require cardiopulmonary bypass at Cardiothoracic Surgical Department, Mansoura University Hospitals.
Key exclusion criteria (10 listed)
- Patients with pulmonary dysfunction or chronic obstructive pulmonary diseases
- Acute or unstable angina
- Previous cardio-thoracic surgery
- Emergency surgery
- Left ventricular ejection fraction less than 40%
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 |
|---|---|---|
| Fentanyl* Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg. * Maintenance of anesthesia (intraoperative until tracheal extubation): Maintenance will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxygen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min. * The patients will receive fentanyl infusion at a rate of 1 µg/kg/h and fentanyl bolus 20-40 µg according to patient hemodynamics. (tachycardia: increase of heart rate >20% of baseline or hypertension: increase of blood pressure >20% of baseline). * After tracheal extubation: all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion. | Drug | High Opioid Group |
| Fentanyl, Propofol* Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg. * Maintenance of anesthesia (intraoperative until tracheal extubation): Maintenance of anesthesia will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxugen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min. * The patients will receive fentanyl bolus 20 µg/hr and propofol 20 mg at the time of surgical stimulation and according to patient hemodynamics (repeated as required). * After tracheal extubation: all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion. | Drug | Low Opioid Group |
| Dexmedetomidine, Ketamine, Magnesium sulfate* Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg. * Maintenance of anesthesia (intraoperative until tracheal extubation): Maintenance of anesthesia will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxygen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min. * The patients will receive infusions of dexmedetomidine 0.2 µg/kg/h, ketamine 2 µg/kg/min, and magnesium sulfate 5 mg/kg/h. * After tracheal extubation: all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion. | Drug | Non-Opioid Group |
Primary outcome
Pain score at rest assessed using the visual analogue scale.
Time frame: 30 minutes after tracheal extubation
visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. orientated from the left (worst) to the right (best) (where 0 is no pain and 100 is the worst pain) lower score means better outcome
14 secondary outcomes
Pain score at rest assessed using the visual analogue scale.
Time frame: 2, 6, 12, and 24 hours after tracheal extubation
Sedation level assessed using Ramsay sedation score
Time frame: 30 minutes, 2, 6, 12, and 24 hours after tracheal extubation
Heart rate
Time frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Systolic blood pressure
Time frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Diastolic blood pressure
Time frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Mean arterial blood pressure
Time frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Total opioid consumption
Time frame: 24 hours post operative
Time to tracheal extubation
Time frame: 2 hours to 6 hours
Duration of ICU stay
Time frame: 2 to 5 days
Time to either bowel movement or flatus
Time frame: within 24 hours
Number of participants with post-operative nausea and vomiting (PONV)
Time frame: within 24 hours
Doses of atropine required
Time frame: from start to the end of surgery
Doses of Inotropic required
Time frame: from start to the end of surgery
Doses of vasopressors required
Time frame: from start to the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fentanyl, Fentanyl, Propofol and Dexmedetomidine, Ketamine, Magnesium sulfate in people with Coronary Artery Disease and Valve Disease, Heart, run by Mansoura University at 1 site in Egypt.
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 10 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: status not confirmed, as of the sponsor's last update on 22 Sep 2021. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Pain score at rest assessed using the visual analogue scale. (time frame: 30 minutes after tracheal extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2021.