Adolescent Idiopathic ScoliosisPhase 2NCT06096181
Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery
A Phase 2 study testing Remifentanil TIVA, Dexmedetomidine TIVA and Propofol TIVA in people with Adolescent Idiopathic Scoliosis and Multimodal Analgesia, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Patients with Adolescent Idiopathic Scoliosis may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid medications is the standard of care. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Multimodal Analgesia, Opioid Induced Hyperalgesia
- What is being tested?
- Remifentanil TIVA, Dexmedetomidine TIVA and Propofol TIVA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2023to 24 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 12-18 years old
- American Society of Anesthesiology Physical Status Classification (ASA Class) 1 and 2
- Have diagnosis of Adolescent Idiopathic Scoliosis
- Undergoing Posterior Spinal Fusion with instrumentation for scoliosis correction
- Matched on age, sex, and the number of vertebral levels fused
Who cannot join
- Neuromuscular scoliosis
- Allergy to any of the multi-modal analgesia regimen drugs
- Use of serotonergic drugs, monoamine oxidase inhibitors (MAOI), mixed agonist/antagonist opioid analgesics
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Prospective Study Comparing Total Intravenous Anesthesia With Propofol and Remifentanil vs. Propofol and Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion and Instrumentation
Patients with Adolescent Idiopathic Scoliosis may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid medications is the standard of care. The purpose of this study is to compare two combinations of total intravenous anesthetic medications in children with Adolescent Idiopathic Scoliosis having posterior spinal fusion surgery.
Participants in the study will be randomly selected to receive either Propofol and Remifentanil or Propofol and Dexmedetomidine as their total intravenous anesthesia (TIVA). TIVA is favored over gas anesthesia because gas anesthesia can affect the neurological monitoring necessary for this surgery.
Read more
The first combination (Propofol + Remifentanil) is the most common one used for this surgery at our institution, and the second combination (Propofol + Dexmedetomidine) is more commonly used in adult spine surgery. Though Dexmedetomidine is not approved for pediatric use by the FDA, it is widely used in pediatric patients for procedural sedation and surgical anesthesia in the US and worldwide. Both anesthetic combinations are used safely in adult and pediatric patients at our institution.
Although remifentanil works fast and is an excellent pain medication during surgery, there are reports that it's use can cause increased pain sensitivity and greater need for narcotic pain medication after surgery. This phenomenon is known as opioid-induced hyperalgesia. The investigators hypothesize that avoiding the use of remifentanil in the TIVA by using dexmedetomidine could avoid OIH and thus result in superior postop pain control.
Our study's primary goal is to measure the total opioid consumption on postoperative days (POD)# 0 and 1. Our secondary goals are to measure the pain scores on a visual analog scale (VAS) on POD# 0 and 1, measure the time it takes for participants to move their feet to command when surgery is done, and measure the time it takes for participants to be extubated when surgery is done. By comparing these measurements, the investigators hope to find out if there is any significant difference between the two TIVAs in terms of postop opioid requirements, pain scores, and time to wake up from anesthesia.
The investigators hope that our study gives us more knowledge on how to better treat postoperative pain in children who have spine surgery to correct their
Read the detailed description
Patients with Adolescent Idiopathic Scoliosis (AIS) may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid medications is the standard of care. Total intravenous anesthesia (TIVA) is the usual anesthetic technique of choice.
The purpose of this study is to compare two combinations of TIVA medications in children AIS having posterior spinal fusion surgery.
The most common TIVA for this surgery at our institution is Propofol + Remifentanil. Remifentanil is a popular choice because of its rapid onset, extremely short context-sensitive half-life, potency, and its rapid recovery from drug effect. However, an important concern with intraoperative remifentanil infusion is the possible development of acute opioid-induced hyperalgesia (OIH). In adults, OIH is a well-documented feature linked to intraoperative remifentanil administration, manifesting as increased postoperative analgesic requirement and paradoxical increase in sensitivity to painful stimuli. In pediatric patients, the phenomenon is not as well characterized.
An alternative TIVA that is very commonly used for adult spine surgery is propofol + dexmedetomidine (DEX). DEX is a highly selective alpha2-adrenergic receptor agonist with sedative, analgesic, and sympatholytic properties.
Despite the lack of FDA approval for pediatric use, DEX is widely used off-label in pediatric patients in the US and worldwide and has previously been shown to be safe and efficacious for various clinical indications including procedural sedation, craniotomy-awake-surgery, cardiac surgery, and posterior spinal fusion for scoliosis. DEX is currently used safely in pediatric and adult spine patients in our institution. The most common adverse effect is intraoperative bradycardia.
Participants will be randomized to receive one of the two TIVAs to see if one or the other results in lower opioid consumption, and lower Visual Analog Scale (VAS) pain scores in the post-operative period (POD# 0 and 1). The investigators hypothesize that the use of DEX will avoid OIH and this will lead to less opioid consumption in the postoperative period, and superior postoperative pain control. The investigators also hope to show that the use of DEX will not significantly prolong time to moving feet to command and extubation at conclusion of surgery.
- Conditions
- Adolescent Idiopathic Scoliosis, Multimodal Analgesia, Opioid Induced Hyperalgesia, Remifentanil, Dexmedetomidine, Posterior Spinal Fusion
- Being tested
- Remifentanil TIVA, Dexmedetomidine TIVA, Propofol TIVA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil TIVADrug
Also called Ultiva TIVA
Remifentanil is more commonly used in the TIVA combination for pediatric patients having this surgery.
Dexmedetomidine TIVADrug
Also called Precedex TIVA
Dexmedetomidine is less commonly used in the TIVA combination for pediatric patients having this surgery.
Propofol TIVADrug
Also called Diprivan TIVA
Propofol is an anesthetic drug that causes sleep during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Propofol + Remifentanil | Active comparator | Participants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) < 55-60 to ensure patient is asleep. Receives: Drug: Remifentanil TIVA; Drug: Propofol TIVA |
| Propofol + Dexmedetomidine | Active comparator | Participants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) < 55-60 to ensure patient is asleep. Receives: Drug: Dexmedetomidine TIVA; Drug: Propofol TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1
Measure the median total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1.
Measured: Post Op Day# 0 and 1
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1
Measure the mean total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1.
Measured: Post Op Day# 0 and 1
Secondary outcomes (3)
Mean VAS Pain Score on POD# 0 and 1
Measure the mean pain score of the participant on a visual analog pain scale. The VAS has two end points representing 0 ("no pain") and 10 ("worst pain ever"). It is reported at our institution as a number between 0 and 10.
Measured: Post Op Day# 0 and 1
Time From Skin Closure to Participant Being Able to Move Their Feet on Command (Mins)
Measure the median time (mins) from completion of surgical skin closure to the participant being able to move their feet to command.
Measured: Intraoperative (day of surgery)
Time From Skin Closure to Extubation
Measure the median time (mins) from completion of surgical skin closure to extubation.
Measured: Intraoperative (day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start20 Dec 2023
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Why it stopped: The primary surgeon decided to prematurely halt the study because he anecdotally felt that one of the trial drugs (Dexmedetomidine) could affect the motor evoked potential monitoring necessary for the surgery.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Tan, M.D., Cedars-Sinai Medical Center
- Investigators
- Glenn Tan, M.D., Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096181
- Sponsor's protocol ID
- STUDY00002614
- Status last verified
- Aug 2024
- First submitted
- 16 Oct 2023
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young CD, McLuckie D, Spencer AO. Anaesthetic care for surgical management of adolescent idiopathic scoliosis. BJA Educ. 2019 Jul;19(7):232-237. doi: 10.1016/j.bjae.2019.03.005. Epub 2019 May 14. No abstract available.
PubMed 33456896Lee CS, Merchant S, Chidambaran V. Postoperative Pain Management in Pediatric Spinal Fusion Surgery for Idiopathic Scoliosis. Paediatr Drugs. 2020 Dec;22(6):575-601. doi: 10.1007/s40272-020-00423-1. Epub 2020 Oct 23.
PubMed 33094437Gall O, Aubineau JV, Berniere J, Desjeux L, Murat I. Analgesic effect of low-dose intrathecal morphine after spinal fusion in children. Anesthesiology. 2001 Mar;94(3):447-52. doi: 10.1097/00000542-200103000-00014.
PubMed 11374604Goodarzi M. The advantages of intrathecal opioids for spinal fusion in children. Paediatr Anaesth. 1998;8(2):131-4. doi: 10.1046/j.1460-9592.1998.00737.x.
PubMed 9549739Eschertzhuber S, Hohlrieder M, Keller C, Oswald E, Kuehbacher G, Innerhofer P. Comparison of high- and low-dose intrathecal morphine for spinal fusion in children. Br J Anaesth. 2008 Apr;100(4):538-43. doi: 10.1093/bja/aen025. Epub 2008 Feb 27.
PubMed 18305080Tripi PA, Poe-Kochert C, Potzman J, Son-Hing JP, Thompson GH. Intrathecal morphine for postoperative analgesia in patients with idiopathic scoliosis undergoing posterior spinal fusion. Spine (Phila Pa 1976). 2008 Sep 15;33(20):2248-51. doi: 10.1097/BRS.0b013e31817bd8be.
PubMed 18794769Ibach BW, Loeber C, Shukry M, Hagemann TM, Harrison D, Johnson PN. Duration of intrathecal morphine effect in children with idiopathic scoliosis undergoing posterior spinal fusion. J Opioid Manag. 2015 Jul-Aug;11(4):295-303. doi: 10.5055/jom.2015.0278.
PubMed 26312956Ross AK, Davis PJ, Dear Gd GL, Ginsberg B, McGowan FX, Stiller RD, Henson LG, Huffman C, Muir KT. Pharmacokinetics of remifentanil in anesthetized pediatric patients undergoing elective surgery or diagnostic procedures. Anesth Analg. 2001 Dec;93(6):1393-401, table of contents. doi: 10.1097/00000539-200112000-00008.
PubMed 11726413Donmez A, Kizilkan A, Berksun H, Varan B, Tokel K. One center's experience with remifentanil infusions for pediatric cardiac catheterization. J Cardiothorac Vasc Anesth. 2001 Dec;15(6):736-9. doi: 10.1053/jcan.2001.28319.
PubMed 11748523German JW, Aneja R, Heard C, Dias M. Continuous remifentanil for pediatric neurosurgery patients. Pediatr Neurosurg. 2000 Nov;33(5):227-229. doi: 10.1159/000055959.
PubMed 11155057Sammartino M, Garra R, Sbaraglia F, De Riso M, Continolo N. Remifentanil in children. Paediatr Anaesth. 2010 Mar;20(3):246-55. doi: 10.1111/j.1460-9592.2009.03241.x. Epub 2010 Jan 21.
PubMed 20102527Kim SH, Stoicea N, Soghomonyan S, Bergese SD. Intraoperative use of remifentanil and opioid induced hyperalgesia/acute opioid tolerance: systematic review. Front Pharmacol. 2014 May 8;5:108. doi: 10.3389/fphar.2014.00108. eCollection 2014.
PubMed 24847273Abreu M, Aguado D, Benito J, Garcia-Fernandez J, Segura IA. Hyperalgesia and increased sevoflurane minimum alveolar concentration induced by opioids in the rat: a randomised experimental study. Eur J Anaesthesiol. 2015 Apr;32(4):232-41. doi: 10.1097/EJA.0000000000000188.
PubMed 25485881Weinbroum AA. Role of anaesthetics and opioids in perioperative hyperalgesia: one step towards familiarisation. Eur J Anaesthesiol. 2015 Apr;32(4):230-1. doi: 10.1097/EJA.0000000000000231. No abstract available.
PubMed 25747314Santonocito C, Noto A, Crimi C, Sanfilippo F. Remifentanil-induced postoperative hyperalgesia: current perspectives on mechanisms and therapeutic strategies. Local Reg Anesth. 2018 Apr 9;11:15-23. doi: 10.2147/LRA.S143618. eCollection 2018.
PubMed 29670398
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing Total Intravenous Anesthesia With Propofol and Remifentanil vs. Propofol and Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion and Instrumentation
- ClinicalTrials.gov ID
- NCT06096181
- Acronym / sponsor ID
- STUDY00002614
- Conditions
- Adolescent Idiopathic Scoliosis, Multimodal Analgesia, Opioid Induced Hyperalgesia, Remifentanil, Dexmedetomidine, Posterior Spinal Fusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The primary surgeon decided to prematurely halt the study because he anecdotally felt that one of the trial drugs (Dexmedetomidine) could affect the motor evoked potential monitoring necessary for the surgery.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Adolescent Idiopathic Scoliosis may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid medications is the standard of care. The purpose of this study is to compare two combinations of total intravenous anesthetic medications in children with Adolescent Idiopathic Scoliosis having posterior spinal fusion surgery.
Participants in the study will be randomly selected to receive either Propofol and Remifentanil or Propofol and Dexmedetomidine as their total intravenous anesthesia (TIVA). TIVA is favored over gas anesthesia because gas anesthesia can affect the neurological monitoring necessary for this surgery.
The first combination (Propofol + Remifentanil) is the most common one used for this surgery at our institution, and the second combination (Propofol + Dexmedetomidine) is more commonly used in adult spine surgery. Though Dexmedetomidine is not approved for pediatric use by the FDA, it is widely used in pediatric patients for procedural sedation and surgical anesthesia in the US and worldwide. Both anesthetic combinations are used safely in adult and pediatric patients at our institution.
Although remifentanil works fast and is an excellent pain medication during surgery, there are reports that it's use can cause increased pain sensitivity and greater need for narcotic pain medication after surgery. This phenomenon is known as opioid-induced hyperalgesia. The investigators hypothesize that avoiding the use of remifentanil in the TIVA by using dexmedetomidine could avoid OIH and thus result in superior postop pain control.
Our study's primary goal is to measure the total opioid consumption on postoperative days (POD)# 0 and 1. Our secondary goals are to measure the pain scores on a visual analog scale (VAS) on POD# 0 and 1, measure the time it takes for participants to move their feet to command when surgery is done, and measure the time it takes for participants to be extubated when surgery is done. By comparing these measurements, the investigators hope to find out if there is any significant difference between the two TIVAs in terms of postop opioid requirements, pain scores, and time to wake up from anesthesia.
The investigators hope that our study gives us more knowledge on how to better treat postoperative pain in children who have spine surgery to correct their
Detailed description
Patients with Adolescent Idiopathic Scoliosis (AIS) may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid medications is the standard of care. Total intravenous anesthesia (TIVA) is the usual anesthetic technique of choice.
The purpose of this study is to compare two combinations of TIVA medications in children AIS having posterior spinal fusion surgery.
The most common TIVA for this surgery at our institution is Propofol + Remifentanil. Remifentanil is a popular choice because of its rapid onset, extremely short context-sensitive half-life, potency, and its rapid recovery from drug effect. However, an important concern with intraoperative remifentanil infusion is the possible development of acute opioid-induced hyperalgesia (OIH). In adults, OIH is a well-documented feature linked to intraoperative remifentanil administration, manifesting as increased postoperative analgesic requirement and paradoxical increase in sensitivity to painful stimuli. In pediatric patients, the phenomenon is not as well characterized.
An alternative TIVA that is very commonly used for adult spine surgery is propofol + dexmedetomidine (DEX). DEX is a highly selective alpha2-adrenergic receptor agonist with sedative, analgesic, and sympatholytic properties.
Despite the lack of FDA approval for pediatric use, DEX is widely used off-label in pediatric patients in the US and worldwide and has previously been shown to be safe and efficacious for various clinical indications including procedural sedation, craniotomy-awake-surgery, cardiac surgery, and posterior spinal fusion for scoliosis. DEX is currently used safely in pediatric and adult spine patients in our institution. The most common adverse effect is intraoperative bradycardia.
Participants will be randomized to receive one of the two TIVAs to see if one or the other results in lower opioid consumption, and lower Visual Analog Scale (VAS) pain scores in the post-operative period (POD# 0 and 1). The investigators hypothesize that the use of DEX will avoid OIH and this will lead to less opioid consumption in the postoperative period, and superior postoperative pain control. The investigators also hope to show that the use of DEX will not significantly prolong time to moving feet to command and extubation at conclusion of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol + Remifentanil | Active comparator | Drug: Remifentanil TIVA, Drug: Propofol TIVAParticipants are randomly selected to receive Propofol + Remifentanil TIVA as their anesthesia. Dose of IV Propofol is 100-200 mcg/kg/min and dose of Remifentanil is 0.2-0.5 mcg/kg/min. TIVA is titrated to keep bispectral index (BIS) < 55-60 to ensure patient is asleep. |
| Propofol + Dexmedetomidine | Active comparator | Drug: Dexmedetomidine TIVA, Drug: Propofol TIVAParticipants are randomly selected to receive Propofol + Dexmedetomidine as their anesthesia. Dose of Propofol is 100-200 mcg/kg/min and dose Dexmedetomidine is ) 0.2-0.7 mcg/kg/hr. TIVA is titrated to beep bispectral index (BIS) < 55-60 to ensure patient is asleep. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 12-18 years old
- American Society of Anesthesiology Physical Status Classification (ASA Class) 1 and 2
- Have diagnosis of Adolescent Idiopathic Scoliosis
- Undergoing Posterior Spinal Fusion with instrumentation for scoliosis correction
- Matched on age, sex, and the number of vertebral levels fused
Key exclusion criteria (3 listed)
- Neuromuscular scoliosis
- Allergy to any of the multi-modal analgesia regimen drugs
- Use of serotonergic drugs, monoamine oxidase inhibitors (MAOI), mixed agonist/antagonist opioid analgesics
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 |
|---|---|---|
| Remifentanil TIVAAlso: Ultiva TIVARemifentanil is more commonly used in the TIVA combination for pediatric patients having this surgery. | Drug | Propofol + Remifentanil |
| Dexmedetomidine TIVAAlso: Precedex TIVADexmedetomidine is less commonly used in the TIVA combination for pediatric patients having this surgery. | Drug | Propofol + Dexmedetomidine |
| Propofol TIVAAlso: Diprivan TIVAPropofol is an anesthetic drug that causes sleep during surgery. | Drug | Propofol + Dexmedetomidine, Propofol + Remifentanil |
Primary outcome
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1
Time frame: Post Op Day# 0 and 1
Measure the median total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1.
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1
Time frame: Post Op Day# 0 and 1
Measure the mean total opioid medications needed by the participants (IV and oral) after surgery on post operative days # 0 and 1.
3 secondary outcomes
Mean VAS Pain Score on POD# 0 and 1
Time frame: Post Op Day# 0 and 1
Time From Skin Closure to Participant Being Able to Move Their Feet on Command (Mins)
Time frame: Intraoperative (day of surgery)
Time From Skin Closure to Extubation
Time frame: Intraoperative (day of surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33456896Young CD, McLuckie D, Spencer AO. Anaesthetic care for surgical management of adolescent idiopathic scoliosis. BJA Educ. 2019 Jul;19(7):232-237. doi: 10.1016/j.bjae.2019.03.005. Epub 2019 May 14. No abstract available.
- Background: PubMed 33094437Lee CS, Merchant S, Chidambaran V. Postoperative Pain Management in Pediatric Spinal Fusion Surgery for Idiopathic Scoliosis. Paediatr Drugs. 2020 Dec;22(6):575-601. doi: 10.1007/s40272-020-00423-1. Epub 2020 Oct 23.
- Background: PubMed 11374604Gall O, Aubineau JV, Berniere J, Desjeux L, Murat I. Analgesic effect of low-dose intrathecal morphine after spinal fusion in children. Anesthesiology. 2001 Mar;94(3):447-52. doi: 10.1097/00000542-200103000-00014.
- Background: PubMed 9549739Goodarzi M. The advantages of intrathecal opioids for spinal fusion in children. Paediatr Anaesth. 1998;8(2):131-4. doi: 10.1046/j.1460-9592.1998.00737.x.
- Background: PubMed 18305080Eschertzhuber S, Hohlrieder M, Keller C, Oswald E, Kuehbacher G, Innerhofer P. Comparison of high- and low-dose intrathecal morphine for spinal fusion in children. Br J Anaesth. 2008 Apr;100(4):538-43. doi: 10.1093/bja/aen025. Epub 2008 Feb 27.
- Background: PubMed 18794769Tripi PA, Poe-Kochert C, Potzman J, Son-Hing JP, Thompson GH. Intrathecal morphine for postoperative analgesia in patients with idiopathic scoliosis undergoing posterior spinal fusion. Spine (Phila Pa 1976). 2008 Sep 15;33(20):2248-51. doi: 10.1097/BRS.0b013e31817bd8be.
- Background: PubMed 26312956Ibach BW, Loeber C, Shukry M, Hagemann TM, Harrison D, Johnson PN. Duration of intrathecal morphine effect in children with idiopathic scoliosis undergoing posterior spinal fusion. J Opioid Manag. 2015 Jul-Aug;11(4):295-303. doi: 10.5055/jom.2015.0278.
- Background: PubMed 11726413Ross AK, Davis PJ, Dear Gd GL, Ginsberg B, McGowan FX, Stiller RD, Henson LG, Huffman C, Muir KT. Pharmacokinetics of remifentanil in anesthetized pediatric patients undergoing elective surgery or diagnostic procedures. Anesth Analg. 2001 Dec;93(6):1393-401, table of contents. doi: 10.1097/00000539-200112000-00008.
- Background: PubMed 11748523Donmez A, Kizilkan A, Berksun H, Varan B, Tokel K. One center's experience with remifentanil infusions for pediatric cardiac catheterization. J Cardiothorac Vasc Anesth. 2001 Dec;15(6):736-9. doi: 10.1053/jcan.2001.28319.
- Background: PubMed 11155057German JW, Aneja R, Heard C, Dias M. Continuous remifentanil for pediatric neurosurgery patients. Pediatr Neurosurg. 2000 Nov;33(5):227-229. doi: 10.1159/000055959.
- Background: PubMed 20102527Sammartino M, Garra R, Sbaraglia F, De Riso M, Continolo N. Remifentanil in children. Paediatr Anaesth. 2010 Mar;20(3):246-55. doi: 10.1111/j.1460-9592.2009.03241.x. Epub 2010 Jan 21.
- Background: PubMed 24847273Kim SH, Stoicea N, Soghomonyan S, Bergese SD. Intraoperative use of remifentanil and opioid induced hyperalgesia/acute opioid tolerance: systematic review. Front Pharmacol. 2014 May 8;5:108. doi: 10.3389/fphar.2014.00108. eCollection 2014.
- 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.
Glenn Tan, M.D. principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remifentanil TIVA, Dexmedetomidine TIVA and Propofol TIVA in people with Adolescent Idiopathic Scoliosis and Multimodal Analgesia, run by Cedars-Sinai Medical Center at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 10 Nov 2025. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Opioid Consumption (IV and PO in MME) on POD# 0 and 1 (time frame: Post Op Day# 0 and 1). The study lists 2 primary outcomes in all. 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 NCT06096181, 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 10 Nov 2025.