Shoulder SurgeryNCT04015284
Intraoperative Pain and Quality of Surgical Block During Shoulder Surgery Assessed by NOL Index
A study testing Suprascapular Nerve Block + Posterior Cord Block and Interscalene Brachial Plexus Block in people with Shoulder Surgery and Regional Anesthesia Morbidity, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Surgery, Regional Anesthesia Morbidity
- What is being tested?
- Suprascapular Nerve Block + Posterior Cord Block and Interscalene Brachial Plexus Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2019to 15 Dec 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status 1,2,3.
- Age 18 years or older
- Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively
Who cannot join
- Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
- Coagulation disorders.
- Patient refusal.
- Anatomical disorders and/or neuropathic disease.
- BMI above 40.
- History of substance abuse.
Show all 11Show fewer
- Chronic use of psychotropic and/or opioid.
- History of psychiatric diseases needing treatment.
- Contraindications to nerve block for shoulder surgery.
- Allergy to remifentanil or any drug in the study protocol.
- Failure of nerve block performed in the preoperative block room
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal
Montreal, Quebec, H1T2M4
About this study
Official title: Intraoperative Pain and Quality of the Surgical Nerve Block During Arthroscopic Shoulder Surgery Assessed by the NOL Index When Comparing the Combined Suprascapular and Posterior Cord Nerve Blocks to the Interscalene Brachial Plexus Block
Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to a posterior cord block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks. This prospective observational study will evaluate the NOL response to surgical stimuli and the opioid requirements intraoperatively in patients undergoing shoulder arthroscopies with either a supraclavicular and posterior cord blocks or an interscalene block.
Study Design: Prospective, randomized open label non-inferiority trial. Subject Population: Adults scheduled to undergo elective shoulder arthroscopy Sample Size: 100 patients Study Duration: Starts February 2019 - Ends February 2021 - Interim analysis at 50 patients Study Center: Maisonneuve-Rosemont Hospital, CEMTL, Montreal, Quebec, Canada
Read the detailed description
The main hypothesis of this study is that the suprascapular block combined with a posterior cord block is not inferior to the interscalene brachial plexus block in terms of intraoperative analgesia. We postulate that intraoperative opioid requirements will not differ significantly in patients who receive either block.
Our secondary objectives will consist in looking at the differences in intraoperative anesthetic consumption, NOL index alterations, postoperative opioid consumption, pain scores, arm motor block, diaphragmatic paresis, patient satisfaction and time for readiness to discharge from PACU. We hypothesize that these outcomes will be similar in both groups, with the exception of a potential reduction in arm motor block and diaphragmatic paresis in the combined suprascapular and posterior cord block group.
After having obtained institutional ethics board approval of the study, patients older than 18 years old, scheduled for a first elective shoulder arthroscopy under general anesthesia will be screened in the pre-anesthesia clinic. They will be approached and the whole study procedures will be explained extensively. Interested patients will be invited to sign the consent form (see appendix). Patients will have the right to opt out at any time. The investigators will meet the patients again on the morning of the surgery to address any concerns. After consent, a study number will be allocated to the patient in ascending order.
Two groups will be evaluated:
- Group A: single shot US-guided suprascapular nerve block with 5 mL ropivacaine 0.5%, then single shot US-guided posterior cord block with 10 ml ropivacaine 0.5%.
- Group B: single shot US-guided interscalene brachial plexus block with 15 mL ropivacaine 0.5%.
Tests will be done to evaluate the nerve block-induced loss of sensation to ice prior to entering the operating room (OR). Diaphragmatic excursion will be evaluated using an abdominal curvilinear ultrasound probe, and will be classified as being normal, paradoxical or immobile. Normal motion is caudad movement during inspiration. Paradoxical motion is cephalad movement during inspiration.
Once in the operating room, all routine monitors are connected. Moreover, the PMD TM monitor as well as the BIS® monitor are connected to the anesthesia machine and to the patient. Both study monitors are switched on and will record their respective indices continuously for the duration of the anesthesia. General anesthesia will be induced with propofol (1-2 mg/kg IV; Pharmascience Inc, Canada), remifentanil (1 µg/kg IV bolus; Teva, Canada) and rocuronium (0.6-1 mg/kg IV; Sandoz Canada Inc). A bolus of dexamethasone 4mg IV will be administered after induction of general anesthesia.
Patients will also have received oral acetaminophen 1g and celecoxib 400 mg preoperatively. Intubation with an endotracheal tube is performed once the patient is adequately paralyzed (no responses to the TOF stimulation). All drugs are given according to the adjusted body weight of the patient. This is calculated with Robinson's formula: where TBW is total body weight and IBW is ideal body weight (21-22). Immediately after intubation, anesthesia is maintained with desflurane while targeting a BIS value between 45 and 55, and a remifentanil infusion and boluses are used for a NOL below 25. At the end of anesthesia, when the surgeon starts closing the wounds, an IV bolus of hydromorphone 7 mcg/kg of adjusted body weight is administered. The remifentanil infusion and desflurane are discontinued when dressing starts. Emergence and extubation are done in the OR. All times (start skin closure, start dressing, stop desflurane and remifentanil) will be precisely reported in the CRF.
- Conditions
- Shoulder Surgery, Regional Anesthesia Morbidity
- Being tested
- Suprascapular Nerve Block + Posterior Cord Block, Interscalene Brachial Plexus Block
- Keywords
- NOL monitoring, regional anesthesia, interscalene brachial plexus block, shoulder arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprascapular Nerve Block + Posterior Cord BlockProcedure or surgery
Also called SSNB+PCB
The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the proximal suprascapular nerve is visualized before it turns toward the suprascapular notch. It is blocked using 5mL of ropivicaine 0.5%. The posterior cord is readily visualized when performing an infraclavicular brachial plexus block. It is blocked using 10mL of ropivicaine 0.5%.
Interscalene Brachial Plexus BlockProcedure or surgery
Also called ISPB
The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the interscalene groove is visualized along with the roots of the brachial plexus. The block is performed with 15mL of ropivacaine 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| SSNB + PCB | Experimental | Single shot US-guided suprascapular nerve block (SSNB) with 5 mL ropivacaine 0.5%, then single shot US-guided posterior cord block (PCB) with 10 ml ropivacaine 0.5%. Receives: Procedure: Suprascapular Nerve Block + Posterior Cord Block |
| ISBPB | Active comparator | Single shot US-guided interscalene brachial plexus block (ISBPB) with 15 mL ropivacaine 0.5%. Receives: Procedure: Interscalene Brachial Plexus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of remifentanil in mcg/kg/h during the surgery period
The main criterion will be evaluating the dose of remifentanil per kg per hour of surgery needed intraoperatively to keep a NOL index below the threshold of 25.
Measured: Intraoperative from incision until wound dressing
Secondary outcomes (18)
NOL response after surgical incisions (area under curve)
NOL response after surgical incisions 1 (located 2 cm inferior and 1 cm medial to posterolateral corner of acromion) of the shoulder (by calculating the area under the curve of NOL for the 5 minutes following incision 1).
Measured: Intraoperative
NOL response after surgical incisions (area under curve)
NOL response after surgical incisions 2 (located slightly inferior to coracoid) of the shoulder (by calculating the area under the curve of NOL for the 5 minutes following incision 1).
Measured: Intraoperative
Total dose remifentanil in mcg
Total dose of remifentanil in mcg from incision until wound dressing
Measured: Intraoperative
Number of remifentanil boluses (n)
Number of remifentanil boluses administered to the patient from incision until wound dressing
Measured: Intraoperative
Desflurance consumption in ml
Intraoperative consumption of desflurane in mL
Measured: Intraoperative from incision until wound dressing
Time to awakening in minutes
Time to awakening in minutes.
Measured: Intraoperative
Time to extubation in minutes
Time to extubation in minutes.
Measured: Intraoperative
PACU pain scores on a scale from 0 to 10
PACU pain scores
Measured: From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum
Grip strength in mmHg
Grip strength before nerve blockade and prior to PACU discharge, as measured in mmHg by a pressure transducer connected to a 1000mL saline bag.
Measured: in PACU e.g. up to 3 hours after surgery maximum
Diaphragmatic paresis induced by the nerve block by ultrasound
Ipsilateral diaphragmatic excursion 30 minutes after block completion (normal, paradoxical or no movement).
Measured: 30 minutes after nerve block and before general anesthesia and surgery, in awake patient
Patient dyspnea on a scale from 0 to 10
Patient dyspnea prior to PACU discharge on a scale from 0 to 10.
Measured: PACU e.g. up to 3 hours after surgery maximum
Time to readiness for discharge from PACU in minutes
Time to readiness for discharge from PACU = time in minutes to reach an Aldrete score at 9 for discharge
Measured: PACU e.g. up to 3 hours after surgery maximum
24h pain scores on a scale from 0 to 10 at rest
24h pain scores, H24
Measured: Postoperative at H24, 24 hours after surgery
48h pain scores on a scale from 0 to 10 at rest
48h pain scores
Measured: Postoperative at H48, 48 hours after surgery
24h pain scores on a scale from 0 to 10 during mobilization
24h pain scores during mobilization
Measured: Postoperative at H24, 24 hours after surgery
Per os postoperative (after PACU discharge) morphine equivalent consumption in mg at 8, 16, 24, 32, 40, 48 hs postoperatively
Per os opioid consumption in mg of equivalent morphine (every 8 hours by nurses or with a diary in patients with same day surgery).
Measured: Postoperative for 2 days 48 hours after surgery
Duration of motor block in minutes strength
Duration of motor block in minutes, as measured by time to return of normal grip strength.
Measured: Postoperative for day 1 H24 24hours after surgery
Patient satisfaction on a scale from 0 to 100
Patient satisfaction at 24 hours on a scale from 0 to 100.
Measured: Postoperative at 24h, 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start15 Sep 2019
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Why it stopped: This type of surgery is no longer done at HMR, relocated to other centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder SurgeryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups of patients. Randomization into groups SSNP + PCB or ISBPB as per randomization list, for a total of 100 patients.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Philippe Richebe, MD, PhD, Principal investigator, CIUSSS de l'Est de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015284
- Sponsor's protocol ID
- 2019-1743
- Status last verified
- Oct 2021
- First submitted
- 8 Apr 2019
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pain and Quality of the Surgical Nerve Block During Arthroscopic Shoulder Surgery Assessed by the NOL Index When Comparing the Combined Suprascapular and Posterior Cord Nerve Blocks to the Interscalene Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT04015284
- Acronym / sponsor ID
- 2019-1743
- Conditions
- Shoulder Surgery, Regional Anesthesia Morbidity
- Keywords
- NOL monitoring, regional anesthesia, interscalene brachial plexus block, shoulder arthroscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This type of surgery is no longer done at HMR, relocated to other centers
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 10 Jul 2019 (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.
Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to a posterior cord block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks. This prospective observational study will evaluate the NOL response to surgical stimuli and the opioid requirements intraoperatively in patients undergoing shoulder arthroscopies with either a supraclavicular and posterior cord blocks or an interscalene block.
Study Design: Prospective, randomized open label non-inferiority trial. Subject Population: Adults scheduled to undergo elective shoulder arthroscopy Sample Size: 100 patients Study Duration: Starts February 2019 - Ends February 2021 - Interim analysis at 50 patients Study Center: Maisonneuve-Rosemont Hospital, CEMTL, Montreal, Quebec, Canada
Detailed description
The main hypothesis of this study is that the suprascapular block combined with a posterior cord block is not inferior to the interscalene brachial plexus block in terms of intraoperative analgesia. We postulate that intraoperative opioid requirements will not differ significantly in patients who receive either block.
Our secondary objectives will consist in looking at the differences in intraoperative anesthetic consumption, NOL index alterations, postoperative opioid consumption, pain scores, arm motor block, diaphragmatic paresis, patient satisfaction and time for readiness to discharge from PACU. We hypothesize that these outcomes will be similar in both groups, with the exception of a potential reduction in arm motor block and diaphragmatic paresis in the combined suprascapular and posterior cord block group.
After having obtained institutional ethics board approval of the study, patients older than 18 years old, scheduled for a first elective shoulder arthroscopy under general anesthesia will be screened in the pre-anesthesia clinic. They will be approached and the whole study procedures will be explained extensively. Interested patients will be invited to sign the consent form (see appendix). Patients will have the right to opt out at any time. The investigators will meet the patients again on the morning of the surgery to address any concerns. After consent, a study number will be allocated to the patient in ascending order.
Two groups will be evaluated:
- Group A: single shot US-guided suprascapular nerve block with 5 mL ropivacaine 0.5%, then single shot US-guided posterior cord block with 10 ml ropivacaine 0.5%.
- Group B: single shot US-guided interscalene brachial plexus block with 15 mL ropivacaine 0.5%.
Tests will be done to evaluate the nerve block-induced loss of sensation to ice prior to entering the operating room (OR). Diaphragmatic excursion will be evaluated using an abdominal curvilinear ultrasound probe, and will be classified as being normal, paradoxical or immobile. Normal motion is caudad movement during inspiration. Paradoxical motion is cephalad movement during inspiration.
Once in the operating room, all routine monitors are connected. Moreover, the PMD TM monitor as well as the BIS® monitor are connected to the anesthesia machine and to the patient. Both study monitors are switched on and will record their respective indices continuously for the duration of the anesthesia. General anesthesia will be induced with propofol (1-2 mg/kg IV; Pharmascience Inc, Canada), remifentanil (1 µg/kg IV bolus; Teva, Canada) and rocuronium (0.6-1 mg/kg IV; Sandoz Canada Inc). A bolus of dexamethasone 4mg IV will be administered after induction of general anesthesia.
Patients will also have received oral acetaminophen 1g and celecoxib 400 mg preoperatively. Intubation with an endotracheal tube is performed once the patient is adequately paralyzed (no responses to the TOF stimulation). All drugs are given according to the adjusted body weight of the patient. This is calculated with Robinson's formula: where TBW is total body weight and IBW is ideal body weight (21-22). Immediately after intubation, anesthesia is maintained with desflurane while targeting a BIS value between 45 and 55, and a remifentanil infusion and boluses are used for a NOL below 25. At the end of anesthesia, when the surgeon starts closing the wounds, an IV bolus of hydromorphone 7 mcg/kg of adjusted body weight is administered. The remifentanil infusion and desflurane are discontinued when dressing starts. Emergence and extubation are done in the OR. All times (start skin closure, start dressing, stop desflurane and remifentanil) will be precisely reported in the CRF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups of patients. Randomization into groups SSNP + PCB or ISBPB as per randomization list, for a total of 100 patients.
| Arm | Type | Receives |
|---|---|---|
| SSNB + PCB | Experimental | Procedure: Suprascapular Nerve Block + Posterior Cord BlockSingle shot US-guided suprascapular nerve block (SSNB) with 5 mL ropivacaine 0.5%, then single shot US-guided posterior cord block (PCB) with 10 ml ropivacaine 0.5%. |
| ISBPB | Active comparator | Procedure: Interscalene Brachial Plexus BlockSingle shot US-guided interscalene brachial plexus block (ISBPB) with 15 mL ropivacaine 0.5%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA status 1,2,3.
- Age 18 years or older
- Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively
Key exclusion criteria (11 listed)
- Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.
- Coagulation disorders.
- Patient refusal.
- Anatomical disorders and/or neuropathic disease.
- BMI above 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 |
|---|---|---|
| Suprascapular Nerve Block + Posterior Cord BlockAlso: SSNB+PCBThe patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the proximal suprascapular nerve is visualized before it turns toward the suprascapular notch. It is blocked using 5mL of ropivicaine 0.5%. The posterior cord is readily visualized when performing an infraclavicular brachial plexus block. It is blocked using 10mL of ropivicaine 0.5%. | Procedure or surgery | SSNB + PCB |
| Interscalene Brachial Plexus BlockAlso: ISPBThe patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the interscalene groove is visualized along with the roots of the brachial plexus. The block is performed with 15mL of ropivacaine 0.5%. | Procedure or surgery | ISBPB |
Primary outcome
Dose of remifentanil in mcg/kg/h during the surgery period
Time frame: Intraoperative from incision until wound dressing
The main criterion will be evaluating the dose of remifentanil per kg per hour of surgery needed intraoperatively to keep a NOL index below the threshold of 25.
18 secondary outcomes
NOL response after surgical incisions (area under curve)
Time frame: Intraoperative
NOL response after surgical incisions (area under curve)
Time frame: Intraoperative
Total dose remifentanil in mcg
Time frame: Intraoperative
Number of remifentanil boluses (n)
Time frame: Intraoperative
Desflurance consumption in ml
Time frame: Intraoperative from incision until wound dressing
Time to awakening in minutes
Time frame: Intraoperative
Time to extubation in minutes
Time frame: Intraoperative
PACU pain scores on a scale from 0 to 10
Time frame: From entrance in PACU until PACU discharge e.g. up to 3 hours after surgery maximum
Grip strength in mmHg
Time frame: in PACU e.g. up to 3 hours after surgery maximum
Diaphragmatic paresis induced by the nerve block by ultrasound
Time frame: 30 minutes after nerve block and before general anesthesia and surgery, in awake patient
Patient dyspnea on a scale from 0 to 10
Time frame: PACU e.g. up to 3 hours after surgery maximum
Time to readiness for discharge from PACU in minutes
Time frame: PACU e.g. up to 3 hours after surgery maximum
24h pain scores on a scale from 0 to 10 at rest
Time frame: Postoperative at H24, 24 hours after surgery
48h pain scores on a scale from 0 to 10 at rest
Time frame: Postoperative at H48, 48 hours after surgery
24h pain scores on a scale from 0 to 10 during mobilization
Time frame: Postoperative at H24, 24 hours after surgery
Per os postoperative (after PACU discharge) morphine equivalent consumption in mg at 8, 16, 24, 32, 40, 48 hs postoperatively
Time frame: Postoperative for 2 days 48 hours after surgery
Duration of motor block in minutes strength
Time frame: Postoperative for day 1 H24 24hours after surgery
Patient satisfaction on a scale from 0 to 100
Time frame: Postoperative at 24h, 24 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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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.
Philippe Richebe, MD, PhD principal investigator
CIUSSS de l'Est de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprascapular Nerve Block + Posterior Cord Block and Interscalene Brachial Plexus Block in people with Shoulder Surgery and Regional Anesthesia Morbidity, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 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: withdrawn, as of the sponsor's last update on 8 Oct 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 Canada. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Dose of remifentanil in mcg/kg/h during the surgery period (time frame: Intraoperative from incision until wound dressing). 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 8 Oct 2021.