AnesthesiaEarly Phase 1NCT04648540
Multimodal Opioid-free Anesthesia Versus Opioid-based Anesthesia for Patients Undergoing Cardiac Valve Surgeries: RCT
A Early Phase 1 study testing Dexmedetomidine 0.5 mic/kg/h and Fentanyl 1 mic/kg/hr in people with Anesthesia, run by Cairo University at 1 site in Egypt.
Trial summary
Several studies demonstrated the effectiveness of OFA in patients undergoing non-cardiac surgery. Preoperative use of Cox inhibitors, GABA analogues and acetaminophen have been shown to decrease use of opioids postoperatively . Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine 0.5 mic/kg/h and Fentanyl 1 mic/kg/hr
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Oct 2022
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing cardiac valve surgeries ( replacement or repair ) .
- Age (18-80) years
- Both sexes
Who cannot join
- Patient refusal
- Known allergy to any of the medications used in the study
- Combined valve and CABG surgeries
- Redo surgery
- Infective endocarditis
- Patients in heart failure or heart block or with significant systolic dysfunction (EF < 40%) or diastolic dysfunction more than grade II
Show all 10Show fewer
- Pregnant females
- Patients being treated for chronic pain or with recent use (< two weeks) of opioids, gabapentin, or pregabalin.
- Substance abuse
- Patients with renal impairment (creatinine > 2 mg/dL) or hepatic impairment (ALT > 2 folds, INR > 1.5 and/or serum albumin < 2.5 g/dl)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Opioid-free Anesthesia Versus Opioid-based Anesthesia for Patients Undergoing Cardiac Valve Surgeries: A Randomized Controlled Trial
Several studies demonstrated the effectiveness of OFA in patients undergoing non-cardiac surgery. Preoperative use of Cox inhibitors, GABA analogues and acetaminophen have been shown to decrease use of opioids postoperatively . Intraoperative use of agents that lead to opioid sparing effects via sodium channel blockade, blockade of G protein-coupled receptors, NMDA blockade, central alpha-2 agonists and anti-inflammatory effects can make opioid-free anesthesia (OFA) possible. On the other hand, there have been no studies demonstrating the effectiveness of an OFA technique in patients undergoing cardiac surgery except for two case reports who successfully implemented the OFA regimen in two patients undergoing valve replacement surgeries. The investigators therefore propose this prospective randomized controlled trial to investigate whether a multimodal opioid-free anesthesia regimen will be suitable as an alternative to conventional opioid-based regimen in patients undergoing valve surgery
Read the detailed description
High-dose opioid anesthesia during cardiac surgery has been the mainstay of cardiac anesthesia for decades due to its ability to preserve hemodynamic stability and attenuate hormonal and metabolic response to surgical stress (1) . However, large doses of long-acting opioids required patients to be ventilated post-operatively for 12-24 h. Modifications in these practices have been dictated by the increasing cost, complications of prolonged mechanical ventilation, and the changes in demographics of patients presenting for cardiac surgery (2) . Moreover, the intraoperative use of large bolus doses or continuous infusions of potent opioids may be associated with postoperative hyperalgesia and tolerance (3). When it comes to ambulatory surgery, opioid related side effects, such as postoperative nausea and vomiting (PONV), prolonged sedation, ileus and urinary retention may delay recovery and discharge or cause unanticipated hospital readmission (4) . Such complications might, at least in part, also apply to cardiac anesthesia.
Recent evidence suggests that increased total dose of opioids during cardiac surgery may lead to increased in-hospital, as well as long-term post-operative pain medication requirements for up to one year (5). Moreover, according to Hirji et al study , ongoing opioid use three months after CABG was present in 21.7% of opioid-exposed patients versus 3.2% of opioid-naive patients (6). In addition, Opioids have many known side effects such as somnolence, brainstem and respiratory depression , and chronic opioid dependence (7-9), and there is a national trend to decrease opioid use during non-cardiac surgery to promote faster recovery and decrease narcotic use post-operatively (1) .
Several studies demonstrated the effectiveness of Opioid-free Anesthesia (OFA) in patients undergoing non-cardiac surgery(4,10,11). Preoperative use of COX inhibitors, GABA analogues and acetaminophen have been shown to decrease use of opioids postoperatively(10). Intraoperative use of agents that lead to opioid sparing effects via sodium channel blockade, blockade of G protein-coupled receptors, NMDA blockade, central alpha-2 agonists and anti-inflammatory effects can make opioid-free anesthesia (OFA) possible (12,13). On the other hand, there have been no studies demonstrating the effectiveness of an OFA technique in patients undergoing cardiac surgery except for two case reports who successfully implemented the OFA regimen in two patients undergoing valve replacement surgeries (14,15). The investigators therefore propose this prospective randomized controlled trial to investigate whether a multimodal opioid-free anesthesia regimen will be suitable as an alternative to conventional opioid-based regimen in patients undergoing valve surgery.
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine 0.5 mic/kg/h, Fentanyl 1 mic/kg/hr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.5 mic/kg/hDrug
Also called Lidocaine 0.5 mg/kg/h, Pregabalin 150 mg, Acetaminophen 1g, Ketorolac 30 mg
In Group I (OFA) the following drugs will be administered preoperatively:
Acetaminophen 1 gm and Ketorolac 30 mg in 100 mL i.v. over 10 minutes Dexmedetomidine loading dose of 0.5 mic/kg i.v. over 10 minutes Lidocaine loading dose of 1.5 mg/kg i.v. over 10 minutes
The following drugs will be administered as a continuous infusion throughout the operation:
- Dexmedetomidine 0.5 mic/kg/h
- Lidocaine 0.5 mg/kg/h
The following drugs will be administered postoperatively:
Acetaminophen 1 gm/6h ketorolac 30 mg/8h Pregabalin 150 mg once at night Celecoxib 200 mg/24 hours
Fentanyl 1 mic/kg/hrDrug
Also called Morphine 0.1 mg/kg/hr
In Group II (OA) patients will receive a continuous infusion of Fentanyl (1 mic/kg/h) Morphine 0.1 mg/kg PRN will be administered every 8 hours for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Free Anesthesia (OFA) | Experimental | The following drugs will be administered 10 minutes before induction of anesthesia in group I (OFA):
* Pregabalin 150 mg orally with a small sip of water
* Acetaminophen 1 gm and Ketorolac 30 mg in 100 mL i.v. over 10 minutes
* Dexmedetomidine loading dose of 0.5 mic/kg i.v. over 10 minutes
* Lidocaine loading dose of 1.5 mg/kg i.v. over 10 minutes
For simplicity, the weight-based doses of dexmedetomidine and lidocaine will be prepared in a 20 mL syringe
the following drugs will be administered as a continuous infusion:
* Dexmedetomidine 0.5 mic/kg/h
* Lidocaine 0.5 mg/kg/h
Patients in both groups will be extubated when they meet our institutional criteria for extubation. Postoperative analgesia will be started as follows:
Group I (OFA):
* Acetaminophen 1 gm/6h
* ketorolac 30 mg/8h
* Pregabalin 150 mg once at night
* Celecoxib 200 mg/24 hours Receives: Drug: Dexmedetomidine 0.5 mic/kg/h |
| Opioid Anesthesia (OA) | Active comparator | Before induction In Group II (OA) patients will receive placebo pills and normal saline in equivalent volumes .
Maintenance
In Group II (OA) patients will receive a continuous infusion of Fentanyl (1 mic/kg/h)
Patients in both groups will be extubated when they meet our institutional criteria for extubation. Postoperative analgesia will be started as follows:
• Morphine 0.1 mg /kg PRN every 8 hours Receives: Drug: Fentanyl 1 mic/kg/hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time (min)
Extubation time, defined as the time from discontinuation of inhalation agents to extubation
Measured: 24 hours
Secondary outcomes (4)
Heart rate (beats/min)
HR
- Arterial blood pressure (systolic, diastolic, and mean)
Measured: 24 hours
Blood pressure (mm Hg)
Systolic, diastolic, and mean blood pressure
Measured: 24 hours
Postoperative rescue analgesia (number)
The number of patients requiring rescue analgesia with Morphine
Measured: 24
Postoperative morphine consumption (mg)
The total dose of morphine administered
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam El-Ashmawi, Cairo University
- Investigators
- hossam El-Ashmawi, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648540
- Sponsor's protocol ID
- MD-242-2019
- Status last verified
- Aug 2023
- First submitted
- 4 Nov 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rong LQ, Kamel MK, Rahouma M, Naik A, Mehta K, Abouarab AA, Di Franco A, Demetres M, Mustapich TL, Fitzgerald MM, Pryor KO, Gaudino M. High-dose versus low-dose opioid anesthesia in adult cardiac surgery: A meta-analysis. J Clin Anesth. 2019 Nov;57:57-62. doi: 10.1016/j.jclinane.2019.03.009. Epub 2019 Mar 11.
PubMed 30870677Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.
PubMed 27616189Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.
PubMed 29739537Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
PubMed 25925031van Gulik L, Ahlers SJ, van de Garde EM, Bruins P, van Boven WJ, Tibboel D, van Dongen EP, Knibbe CA. Remifentanil during cardiac surgery is associated with chronic thoracic pain 1 yr after sternotomy. Br J Anaesth. 2012 Oct;109(4):616-22. doi: 10.1093/bja/aes247. Epub 2012 Jul 24.
PubMed 22831889Hirji SA, Landino S, Cote C, Lee J, Orhurhu V, Shah RM, McGurk S, Kaneko T, Shekar P, Pelletier MP. Chronic opioid use after coronary bypass surgery. J Card Surg. 2019 Feb;34(2):67-73. doi: 10.1111/jocs.13981. Epub 2019 Jan 9.
PubMed 30625257Macintyre PE, Walker SM. The scientific evidence for acute pain treatment. Curr Opin Anaesthesiol. 2010 Oct;23(5):623-8. doi: 10.1097/ACO.0b013e32833c33ed.
PubMed 20811175Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.
PubMed 16508405Alam A, Juurlink DN. The prescription opioid epidemic: an overview for anesthesiologists. Can J Anaesth. 2016 Jan;63(1):61-8. doi: 10.1007/s12630-015-0520-y. Epub 2015 Oct 27.
PubMed 26507535McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
PubMed 20518581James MF. Magnesium: an emerging drug in anaesthesia. Br J Anaesth. 2009 Oct;103(4):465-7. doi: 10.1093/bja/aep242. No abstract available.
PubMed 19749114Landry E, Burns S, Pelletier MP, Muehlschlegel JD. A Successful Opioid-Free Anesthetic in a Patient Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2517-2520. doi: 10.1053/j.jvca.2018.11.040. Epub 2018 Nov 28. No abstract available.
PubMed 30611614Cardinale JP, Gilly G. Opiate-Free Tricuspid Valve Replacement: Case Report. Semin Cardiothorac Vasc Anesth. 2018 Dec;22(4):407-413. doi: 10.1177/1089253218771342. Epub 2018 Apr 20.
PubMed 29676223Salah M, Hosny H, Salah M, Saad H. Impact of immediate versus delayed tracheal extubation on length of ICU stay of cardiac surgical patients, a randomized trial. Heart Lung Vessel. 2015;7(4):311-9.
PubMed 26811837
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Opioid-free Anesthesia Versus Opioid-based Anesthesia for Patients Undergoing Cardiac Valve Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04648540
- Acronym / sponsor ID
- MD-242-2019
- Conditions
- Anesthesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 1 Dec 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.
Several studies demonstrated the effectiveness of OFA in patients undergoing non-cardiac surgery. Preoperative use of Cox inhibitors, GABA analogues and acetaminophen have been shown to decrease use of opioids postoperatively . Intraoperative use of agents that lead to opioid sparing effects via sodium channel blockade, blockade of G protein-coupled receptors, NMDA blockade, central alpha-2 agonists and anti-inflammatory effects can make opioid-free anesthesia (OFA) possible. On the other hand, there have been no studies demonstrating the effectiveness of an OFA technique in patients undergoing cardiac surgery except for two case reports who successfully implemented the OFA regimen in two patients undergoing valve replacement surgeries. The investigators therefore propose this prospective randomized controlled trial to investigate whether a multimodal opioid-free anesthesia regimen will be suitable as an alternative to conventional opioid-based regimen in patients undergoing valve surgery
Detailed description
High-dose opioid anesthesia during cardiac surgery has been the mainstay of cardiac anesthesia for decades due to its ability to preserve hemodynamic stability and attenuate hormonal and metabolic response to surgical stress (1) . However, large doses of long-acting opioids required patients to be ventilated post-operatively for 12-24 h. Modifications in these practices have been dictated by the increasing cost, complications of prolonged mechanical ventilation, and the changes in demographics of patients presenting for cardiac surgery (2) . Moreover, the intraoperative use of large bolus doses or continuous infusions of potent opioids may be associated with postoperative hyperalgesia and tolerance (3). When it comes to ambulatory surgery, opioid related side effects, such as postoperative nausea and vomiting (PONV), prolonged sedation, ileus and urinary retention may delay recovery and discharge or cause unanticipated hospital readmission (4) . Such complications might, at least in part, also apply to cardiac anesthesia.
Recent evidence suggests that increased total dose of opioids during cardiac surgery may lead to increased in-hospital, as well as long-term post-operative pain medication requirements for up to one year (5). Moreover, according to Hirji et al study , ongoing opioid use three months after CABG was present in 21.7% of opioid-exposed patients versus 3.2% of opioid-naive patients (6). In addition, Opioids have many known side effects such as somnolence, brainstem and respiratory depression , and chronic opioid dependence (7-9), and there is a national trend to decrease opioid use during non-cardiac surgery to promote faster recovery and decrease narcotic use post-operatively (1) .
Several studies demonstrated the effectiveness of Opioid-free Anesthesia (OFA) in patients undergoing non-cardiac surgery(4,10,11). Preoperative use of COX inhibitors, GABA analogues and acetaminophen have been shown to decrease use of opioids postoperatively(10). Intraoperative use of agents that lead to opioid sparing effects via sodium channel blockade, blockade of G protein-coupled receptors, NMDA blockade, central alpha-2 agonists and anti-inflammatory effects can make opioid-free anesthesia (OFA) possible (12,13). On the other hand, there have been no studies demonstrating the effectiveness of an OFA technique in patients undergoing cardiac surgery except for two case reports who successfully implemented the OFA regimen in two patients undergoing valve replacement surgeries (14,15). The investigators therefore propose this prospective randomized controlled trial to investigate whether a multimodal opioid-free anesthesia regimen will be suitable as an alternative to conventional opioid-based regimen in patients undergoing valve surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Free Anesthesia (OFA) | Experimental | Drug: Dexmedetomidine 0.5 mic/kg/hThe following drugs will be administered 10 minutes before induction of anesthesia in group I (OFA): * Pregabalin 150 mg orally with a small sip of water * Acetaminophen 1 gm and Ketorolac 30 mg in 100 mL i.v. over 10 minutes * Dexmedetomidine loading dose of 0.5 mic/kg i.v. over 10 minutes * Lidocaine loading dose of 1.5 mg/kg i.v. over 10 minutes For simplicity, the weight-based doses of dexmedetomidine and lidocaine will be prepared in a 20 mL syringe the following drugs will be administered as a continuous infusion: * Dexmedetomidine 0.5 mic/kg/h * Lidocaine 0.5 mg/kg/h Patients in both groups will be extubated when they meet our institutional criteria for extubation. Postoperative analgesia will be started as follows: Group I (OFA): * Acetaminophen 1 gm/6h * ketorolac 30 mg/8h * Pregabalin 150 mg once at night * Celecoxib 200 mg/24 hours |
| Opioid Anesthesia (OA) | Active comparator | Drug: Fentanyl 1 mic/kg/hrBefore induction In Group II (OA) patients will receive placebo pills and normal saline in equivalent volumes . Maintenance In Group II (OA) patients will receive a continuous infusion of Fentanyl (1 mic/kg/h) Patients in both groups will be extubated when they meet our institutional criteria for extubation. Postoperative analgesia will be started as follows: • Morphine 0.1 mg /kg PRN every 8 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing cardiac valve surgeries ( replacement or repair ) .
- Age (18-80) years
- Both sexes
Key exclusion criteria (10 listed)
- Patient refusal
- Known allergy to any of the medications used in the study
- Combined valve and CABG surgeries
- Redo surgery
- Infective endocarditis
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 0.5 mic/kg/hAlso: Lidocaine 0.5 mg/kg/h, Pregabalin 150 mg, Acetaminophen 1g, Ketorolac 30 mgIn Group I (OFA) the following drugs will be administered preoperatively: Acetaminophen 1 gm and Ketorolac 30 mg in 100 mL i.v. over 10 minutes Dexmedetomidine loading dose of 0.5 mic/kg i.v. over 10 minutes Lidocaine loading dose of 1.5 mg/kg i.v. over 10 minutes The following drugs will be administered as a continuous infusion throughout the operation: * Dexmedetomidine 0.5 mic/kg/h * Lidocaine 0.5 mg/kg/h The following drugs will be administered postoperatively: Acetaminophen 1 gm/6h ketorolac 30 mg/8h Pregabalin 150 mg once at night Celecoxib 200 mg/24 hours | Drug | Opioid-Free Anesthesia (OFA) |
| Fentanyl 1 mic/kg/hrAlso: Morphine 0.1 mg/kg/hrIn Group II (OA) patients will receive a continuous infusion of Fentanyl (1 mic/kg/h) Morphine 0.1 mg/kg PRN will be administered every 8 hours for postoperative analgesia | Drug | Opioid Anesthesia (OA) |
Primary outcome
Extubation time (min)
Time frame: 24 hours
Extubation time, defined as the time from discontinuation of inhalation agents to extubation
4 secondary outcomes
Heart rate (beats/min)
Time frame: 24 hours
Blood pressure (mm Hg)
Time frame: 24 hours
Postoperative rescue analgesia (number)
Time frame: 24
Postoperative morphine consumption (mg)
Time frame: 24 hours
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 30 Aug 2023.
- Background: PubMed 30870677Rong LQ, Kamel MK, Rahouma M, Naik A, Mehta K, Abouarab AA, Di Franco A, Demetres M, Mustapich TL, Fitzgerald MM, Pryor KO, Gaudino M. High-dose versus low-dose opioid anesthesia in adult cardiac surgery: A meta-analysis. J Clin Anesth. 2019 Nov;57:57-62. doi: 10.1016/j.jclinane.2019.03.009. Epub 2019 Mar 11.
- Background: PubMed 27616189Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.
- Background: PubMed 29739537Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17.
- Background: PubMed 25925031Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.
- Background: PubMed 22831889van Gulik L, Ahlers SJ, van de Garde EM, Bruins P, van Boven WJ, Tibboel D, van Dongen EP, Knibbe CA. Remifentanil during cardiac surgery is associated with chronic thoracic pain 1 yr after sternotomy. Br J Anaesth. 2012 Oct;109(4):616-22. doi: 10.1093/bja/aes247. Epub 2012 Jul 24.
- Background: PubMed 30625257Hirji SA, Landino S, Cote C, Lee J, Orhurhu V, Shah RM, McGurk S, Kaneko T, Shekar P, Pelletier MP. Chronic opioid use after coronary bypass surgery. J Card Surg. 2019 Feb;34(2):67-73. doi: 10.1111/jocs.13981. Epub 2019 Jan 9.
- Background: PubMed 20811175Macintyre PE, Walker SM. The scientific evidence for acute pain treatment. Curr Opin Anaesthesiol. 2010 Oct;23(5):623-8. doi: 10.1097/ACO.0b013e32833c33ed.
- Background: PubMed 16508405Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.
- Background: PubMed 26507535Alam A, Juurlink DN. The prescription opioid epidemic: an overview for anesthesiologists. Can J Anaesth. 2016 Jan;63(1):61-8. doi: 10.1007/s12630-015-0520-y. Epub 2015 Oct 27.
- Background: PubMed 20518581McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
- Background: PubMed 19749114James MF. Magnesium: an emerging drug in anaesthesia. Br J Anaesth. 2009 Oct;103(4):465-7. doi: 10.1093/bja/aep242. No abstract available.
- Background: PubMed 30611614Landry E, Burns S, Pelletier MP, Muehlschlegel JD. A Successful Opioid-Free Anesthetic in a Patient Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2517-2520. doi: 10.1053/j.jvca.2018.11.040. Epub 2018 Nov 28. No abstract available.
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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.
hossam El-Ashmawi, Professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexmedetomidine 0.5 mic/kg/h and Fentanyl 1 mic/kg/hr in people with Anesthesia, run by Cairo 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 3 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: finished, as of the sponsor's last update on 30 Aug 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 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Extubation time (min) (time frame: 24 hours). 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 NCT04648540, which also lists 14 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 30 Aug 2023.