AnalgesiaPhase 3NCT05099055
Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study
A Phase 3 study testing Dexmedetomidine 0.004 MG/ML [Precedex] and Opioids in people with Analgesia and Analgesics, Opioid, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Analgesia, Analgesics, Opioid, Anesthesia, Obstetrical
- What is being tested?
- Dexmedetomidine 0.004 MG/ML [Precedex] and Opioids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2022to 5 May 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient will receive an elective c-section under spinal anesthesia
- Gestational age > 37 weeks
Who cannot join
- ASA score ≥ 3
- Allergy or contraindication to receiving opioids (morphine or fentanyl)
- Allergy or contraindication to receiving anti-inflammatory drugs (ketorolac, Naprosyn)
- Allergy or contraindication to receiving acetaminophen
- Height <152 cm or> 183 cm
- Weight <50 or> 110 kg
Show all 11Show fewer
- Contraindication to spinal anesthesia
- Conversion to general anesthesia
- Combined spinal-epidural anesthesia
- Inability to give informed consent, either secondary to a mental or physical disability or a significant language barrier (Inability to understand English or French)
- Need for transfusion or other major complication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Comme Adjuvant à la rachianesthésie Lors de césariennes électives : Une étude Pilote
The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section.
The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.
Read the detailed description
52 patients will be recruted for this study, and will be randomized in two equal groups.
All the interventions carried out will be standardized. Medical care for patients will be the same as usual care, except for administration of dexmedetomidine or intrathecal narcotics.
In the test group, bupivacaine (12 mg, 1.6 ml) will be injected with 3 mcg of dexemedetomidine.
In the second group, bupivacaine (12 mg, 1.6 ml) will be injected with 100 mcg of morphine and 15 mcg of fentanyl with 0.25 ml of normal saline, which corresponds to the standard treatment.
The patients will receive standard analgesia, described in the protocol, post-operatively and will also have access to anti-nausea and anti-pruritics.
The patient will then be seen the day after surgery to collect her validated self-assessment scales for pain, nausea and vomiting, pruritus, chills and complete her QoR15 questionnaire.
This will be collected to establish preliminary data for a second study of non-inferiority for analgesia and gradation of side effects.
- Conditions
- Analgesia, Analgesics, Opioid, Anesthesia, Obstetrical, Anesthesia, Spinal, Analgesics, Non-Narcotic, Dexmedetomidine
- Being tested
- Dexmedetomidine 0.004 MG/ML [Precedex], Opioids
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.004 MG/ML [Precedex]Drug
Injection of 3 mcg of dexmedetomidine and 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.
OpioidsDrug
Injection of 100 mcg of morphine, 15 mcg of fentanyl and 0.25 ml of normal salin (sterile) with 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Monitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with dexmedetomidine 3 mcg (0.75 mL) previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus. Receives: Drug: Dexmedetomidine 0.004 MG/ML [Precedex] |
| Control group | Active comparator | Monitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with morphine 100 mcg, fentanyl 15 mcg and normal saline 0.25 ml previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus. Receives: Drug: Opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 3 study feasability
The primary outcome will be to evaluate the phase 3 study feasability through recrutement rates and time needed to recrut a total of 52 patients
Measured: 3 months
Secondary outcomes (6)
Opioids consumption
Total morphine equivalent consumed by the patient
Measured: 24 hours post-operatively
Pruritus
Self-assessed validated numerical pruritus scale (NPS). Scale between 0 and 10, 10 being the worst symptoms the patient can imagine.
Measured: 2, 6, 12 and 24 hours after surgery
Nausea
Absence or presence of nausea / vomiting at 2, 6, 12 and 24 hours after surgery
Measured: 2, 6, 12 and 24 hours after surgery
Pain level
Self-assessed validated numerical pain scale (NPS).Scale between 0 and 10, 10 being the worst symptoms the patient can imagine.
Measured: 2, 6, 12 and 24 hours after surgery
Quality of recovery and patient's satisfaction
Satisfaction according to the QoR15 questionnaire. Questionnaire containing 15 question to evaluate the quality of recovery in patients after a surgery.
Measured: 24 hours after surgery
Nausea
Number of anti-nausea medication doses needed
Measured: 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start15 Mar 2022
- Primary completion20 Jan 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Model description
- Pilot study for a phase 3 study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Lamontagne, St. Justine's Hospital
- Investigators
- Christina Lamontagne, Study director, Ste-Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099055
- Sponsor's protocol ID
- 2022-3543
- Status last verified
- May 2023
- First submitted
- 17 Oct 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gu J, Karmakar-Hore S, Hogan ME, Azzam HM, Barrett JFR, Brown A, Cook JL, Jain V, Melamed N, Smith GN, Zaltz A, Gurevich Y. Examining Cesarean Section Rates in Canada Using the Modified Robson Classification. J Obstet Gynaecol Can. 2020 Jun;42(6):757-765. doi: 10.1016/j.jogc.2019.09.009. Epub 2019 Dec 26.
PubMed 31883751Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.
PubMed 20334736American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 2007 Apr;106(4):843-63. doi: 10.1097/01.anes.0000264744.63275.10. No abstract available.
PubMed 17413923Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018.
PubMed 9952150Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
PubMed 10598635Chaney MA. Side effects of intrathecal and epidural opioids. Can J Anaesth. 1995 Oct;42(10):891-903. doi: 10.1007/BF03011037.
PubMed 8706199Goldberg RF. The Opioid Crisis: The Surgeon's Role. Adv Surg. 2019 Sep;53:305-325. doi: 10.1016/j.yasu.2019.04.015. Epub 2019 May 17. No abstract available.
PubMed 31327454Volkow ND, Blanco C. The changing opioid crisis: development, challenges and opportunities. Mol Psychiatry. 2021 Jan;26(1):218-233. doi: 10.1038/s41380-020-0661-4. Epub 2020 Feb 4.
PubMed 32020048Coussens NP, Sittampalam GS, Jonson SG, Hall MD, Gorby HE, Tamiz AP, McManus OB, Felder CC, Rasmussen K. The Opioid Crisis and the Future of Addiction and Pain Therapeutics. J Pharmacol Exp Ther. 2019 Nov;371(2):396-408. doi: 10.1124/jpet.119.259408. Epub 2019 Sep 3.
PubMed 31481516Pan PH. Post cesarean delivery pain management: multimodal approach. Int J Obstet Anesth. 2006 Jul;15(3):185-8. doi: 10.1016/j.ijoa.2006.04.004. No abstract available.
PubMed 16798441Li R, Qi F, Zhang J, Ji Y, Zhang D, Shen Z, Lei W. Antinociceptive effects of dexmedetomidine via spinal substance P and CGRP. Transl Neurosci. 2015 Dec 16;6(1):259-264. doi: 10.1515/tnsci-2015-0028. eCollection 2015.
PubMed 28123811Kerai S, Saxena KN, Taneja B. Post-caesarean analgesia: What is new? Indian J Anaesth. 2017 Mar;61(3):200-214. doi: 10.4103/ija.IJA_313_16.
PubMed 28405033Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.
PubMed 27089000Al-Mustafa MM, Abu-Halaweh SA, Aloweidi AS, Murshidi MM, Ammari BA, Awwad ZM, Al-Edwan GM, Ramsay MA. Effect of dexmedetomidine added to spinal bupivacaine for urological procedures. Saudi Med J. 2009 Mar;30(3):365-70.
PubMed 19271064Qi X, Chen D, Li G, Huang X, Li Y, Wang X, Li Y. Comparison of Intrathecal Dexmedetomidine with Morphine as Adjuvants in Cesarean Sections. Biol Pharm Bull. 2016 Sep 1;39(9):1455-60. doi: 10.1248/bpb.b16-00145. Epub 2016 Jun 28.
PubMed 27349272
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Comme Adjuvant à la rachianesthésie Lors de césariennes électives : Une étude Pilote
- ClinicalTrials.gov ID
- NCT05099055
- Acronym / sponsor ID
- 2022-3543
- Conditions
- Analgesia, Analgesics, Opioid, Anesthesia, Obstetrical, Anesthesia, Spinal, Analgesics, Non-Narcotic, Dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 29 Oct 2021 (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.
The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section.
The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.
Detailed description
52 patients will be recruted for this study, and will be randomized in two equal groups.
All the interventions carried out will be standardized. Medical care for patients will be the same as usual care, except for administration of dexmedetomidine or intrathecal narcotics.
In the test group, bupivacaine (12 mg, 1.6 ml) will be injected with 3 mcg of dexemedetomidine.
In the second group, bupivacaine (12 mg, 1.6 ml) will be injected with 100 mcg of morphine and 15 mcg of fentanyl with 0.25 ml of normal saline, which corresponds to the standard treatment.
The patients will receive standard analgesia, described in the protocol, post-operatively and will also have access to anti-nausea and anti-pruritics.
The patient will then be seen the day after surgery to collect her validated self-assessment scales for pain, nausea and vomiting, pruritus, chills and complete her QoR15 questionnaire.
This will be collected to establish preliminary data for a second study of non-inferiority for analgesia and gradation of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Pilot study for a phase 3 study.
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Dexmedetomidine 0.004 MG/ML [Precedex]Monitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with dexmedetomidine 3 mcg (0.75 mL) previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus. |
| Control group | Active comparator | Drug: OpioidsMonitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with morphine 100 mcg, fentanyl 15 mcg and normal saline 0.25 ml previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient will receive an elective c-section under spinal anesthesia
- Gestational age > 37 weeks
Key exclusion criteria (11 listed)
- ASA score ≥ 3
- Allergy or contraindication to receiving opioids (morphine or fentanyl)
- Allergy or contraindication to receiving anti-inflammatory drugs (ketorolac, Naprosyn)
- Allergy or contraindication to receiving acetaminophen
- Height <152 cm or> 183 cm
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 |
|---|---|---|
| Dexmedetomidine 0.004 MG/ML [Precedex]Injection of 3 mcg of dexmedetomidine and 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia. | Drug | Test group |
| OpioidsInjection of 100 mcg of morphine, 15 mcg of fentanyl and 0.25 ml of normal salin (sterile) with 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia. | Drug | Control group |
Primary outcome
Phase 3 study feasability
Time frame: 3 months
The primary outcome will be to evaluate the phase 3 study feasability through recrutement rates and time needed to recrut a total of 52 patients
6 secondary outcomes
Opioids consumption
Time frame: 24 hours post-operatively
Pruritus
Time frame: 2, 6, 12 and 24 hours after surgery
Nausea
Time frame: 2, 6, 12 and 24 hours after surgery
Pain level
Time frame: 2, 6, 12 and 24 hours after surgery
Quality of recovery and patient's satisfaction
Time frame: 24 hours after surgery
Nausea
Time frame: 24 hours post-operatively
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 9 May 2023.
- Background: PubMed 31883751Gu J, Karmakar-Hore S, Hogan ME, Azzam HM, Barrett JFR, Brown A, Cook JL, Jain V, Melamed N, Smith GN, Zaltz A, Gurevich Y. Examining Cesarean Section Rates in Canada Using the Modified Robson Classification. J Obstet Gynaecol Can. 2020 Jun;42(6):757-765. doi: 10.1016/j.jogc.2019.09.009. Epub 2019 Dec 26.
- Background: PubMed 20334736Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.
- Background: PubMed 17413923American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 2007 Apr;106(4):843-63. doi: 10.1097/01.anes.0000264744.63275.10. No abstract available.
- Background: PubMed 9952150Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018.
- Background: PubMed 10598635Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
- Background: PubMed 8706199Chaney MA. Side effects of intrathecal and epidural opioids. Can J Anaesth. 1995 Oct;42(10):891-903. doi: 10.1007/BF03011037.
- Background: PubMed 31327454Goldberg RF. The Opioid Crisis: The Surgeon's Role. Adv Surg. 2019 Sep;53:305-325. doi: 10.1016/j.yasu.2019.04.015. Epub 2019 May 17. No abstract available.
- Background: PubMed 32020048Volkow ND, Blanco C. The changing opioid crisis: development, challenges and opportunities. Mol Psychiatry. 2021 Jan;26(1):218-233. doi: 10.1038/s41380-020-0661-4. Epub 2020 Feb 4.
- Background: PubMed 31481516Coussens NP, Sittampalam GS, Jonson SG, Hall MD, Gorby HE, Tamiz AP, McManus OB, Felder CC, Rasmussen K. The Opioid Crisis and the Future of Addiction and Pain Therapeutics. J Pharmacol Exp Ther. 2019 Nov;371(2):396-408. doi: 10.1124/jpet.119.259408. Epub 2019 Sep 3.
- Background: PubMed 16798441Pan PH. Post cesarean delivery pain management: multimodal approach. Int J Obstet Anesth. 2006 Jul;15(3):185-8. doi: 10.1016/j.ijoa.2006.04.004. No abstract available.
- Background: PubMed 28123811Li R, Qi F, Zhang J, Ji Y, Zhang D, Shen Z, Lei W. Antinociceptive effects of dexmedetomidine via spinal substance P and CGRP. Transl Neurosci. 2015 Dec 16;6(1):259-264. doi: 10.1515/tnsci-2015-0028. eCollection 2015.
- Background: PubMed 28405033Kerai S, Saxena KN, Taneja B. Post-caesarean analgesia: What is new? Indian J Anaesth. 2017 Mar;61(3):200-214. doi: 10.4103/ija.IJA_313_16.
- Individual participant dataSharing planned: No
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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.
Christina Lamontagne study director
Ste-Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine 0.004 MG/ML [Precedex] and Opioids in people with Analgesia and Analgesics, Opioid, run by St. Justine's Hospital 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 2 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 9 May 2023. 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.
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?
Phase 3 study feasability (time frame: 3 months). 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 NCT05099055, which also lists 39 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 9 May 2023.