Opioid Free AnesthesiaNCT07843953
Intraoperative Infusion of Dexmedetomidine Versus Lidocaine or Magnesium Sulphate for Enhanced Quality of Recovery After Spine Surgery Fixation
A study testing Group ( L): LICOCAINE, GROUP Dexmedetomidine and Group M: Magnesium sulphate in people with Opioid Free Anesthesia and Opioid Based Anesthesia, run by Zagazig University.
Trial summary
Thoracolumbar fixation is a major spine surgery; it is performed to stabilize the spine after trauma, deformity or advanced degenerative disease. The primary surgical goals are to restore spinal alignment and achieve solid arthrodesis (fusion). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Free Anesthesia, Opioid Based Anesthesia, Spine Fixation Surgeries
- What is being tested?
- Group ( L): LICOCAINE, GROUP Dexmedetomidine and Group M: Magnesium sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 1 Jan 2027
- Phase
- Interventional
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient acceptance.
- Patients age between 18-60 years old.
- 2- Both sexes. 3- Physical status from ASA I to III. 4- BMI ≥ 18 kg/m2 \& ≤ 35 kg/m2. 5- Patient acceptance with written consent. 6- Elective lumbar fixation double level surgery
Who cannot join
- Uncooperative patient.
- Allergy to study drugs.
- Patients on chronic alcohol, opioid, tranquilizer or sedative use.
- Pregnancy.
- Emergency surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Thoracolumbar fixation is a major spine surgery; it is performed to stabilize the spine after trauma, deformity or advanced degenerative disease. The primary surgical goals are to restore spinal alignment and achieve solid arthrodesis (fusion). From a surgical view, success is often measured by radiographic outcomes, hardware integrity and fusion rates. As anesthesiologists, we must recognize that technical success does not the same as optimal patient recovery.
This is why the concept of Quality of Recovery (QoR) becomes very important. QoR is a patient-centered outcome that covers more than the absence of surgical complications. It includes rapid return of physical function, pain control, psychological well-being, emotional stability and Patient satisfaction.
Read more
Therefore, our focus in the perioperative care shifts the focus from "did the surgery succeed?" to "how we can help the patient to recover physically, mentally, and functionally?" This approach is measured using patient-reported outcomes such as the QoR-15 or QoR-40 questionnaires.
Dexmedetomidine (Precedex) has become one of the most valuable medications in modern anesthesia, especially for surgeries associated with significant pain. As a highly selective α2-adrenergic agonist, dexmedetomidine provides a unique combination of analgesia, anxiolysis, and cooperative sedation without causing respiratory depression; it is helpful during painful procedures such as spine surgery.
When infused intraoperative; Precedex reduces central sensitization and diminishes the stress response to surgical stimuli, resulting in improved intraoperative hemodynamic stability, lower postoperative pain scores, reduced opioid requirements, and a smooth and calm recovery from anesthesia.
Intraoperative intravenous lidocaine infusion has become an important tool for improving postoperative pain control; especially in major surgeries. Although lidocaine is commonly known as a local anesthetic, when given systemically during surgery it works in several meaningful ways: it calms the central nervous system, reduces the body's inflammatory response to tissue trauma, and decreases pain sensitivity that often appears after anesthesia wears off.
Because of these combined effects, patients who receive IV lidocaine typically experience lower postoperative pain scores and need less opioid medications; therefore, avoid many opioid-related side effects such as nausea, sedation and constipation.
Lidocaine infusion not only reduces early postoperative pain but also help for faster recovery, earlier mobilization, and improved overall patient satisfaction.
Magnesium sulfate has become an increasingly valuable tool for anesthesiologists caring for patients undergoing long and painful surgical procedures. During major surgeries, the body's stress response can increase pain and make anesthetic management more challenging.
Magnesium works by blocking NMDA receptors, which are the key player in central sensitization and postoperative hyperalgesia. This means patients wake up with less pain, lower opioid requirements, and often more stable intraoperative vital signs. Many doctors preferred to use magnesium sulphate because it is inexpensive, widely available, and easy to administer as a slow infusion.
Read the detailed description
QoR -40 Questioner:
The QoR-40 contains 40 questions grouped into 5 dimensions:
- Physical Comfort (12 items)
- Able to breathe easily
- Have had good sleep
- Have felt comfortable
- Have had a good appetite
- Able to enjoy food
- No nausea
- No vomiting
- Feeling rested
- Feeling warm and comfortable
- No shivering
- No sweating
- Have had good general comfort
- Emotional State (9 items) 13. Been able to feel relaxed 14. Been in control 15. Been able to enjoy company of others. 16. Felt anxious 17. Felt angry or irritable 18. Felt depressed 19. Felt lonely 20. Felt confused 21. Felt frightened 3. Physical Independence (5 items) 22. Able to look after personal toilet and hygiene unaided 23. Able to write (or use your phone) 24. Able to speak normally 25. Able to wash yourself 26. Able to dress yourself 4. Psychological Support (7 items) 27. Able to communicate with family or friends 28. Able to communicate with hospital staff 29. Feeling supported by hospital staff 30. Feeling understood by others 31. Feeling supported by family or friends 32. Feeling able to share worries or concerns 33. Feeling encouraged by others 5. Pain (7 items) 34. Moderate pain 35. Severe pain 36. Headache 37. Muscle pains 38. Back pain 39. Sore throat 40. Pain affecting sleep
Scoring
Each item is scored on a 5-point Likert scale:
- = None of the time
- = Some of the time
- = Usually
- = Most of the time
- = All of the time Total score range: 40-200
- 150-200 --- excellent recovery
- 140-159 --- good recovery
- Less than 140 --- moderate recovery
- Conditions
- Opioid Free Anesthesia, Opioid Based Anesthesia, Spine Fixation Surgeries, Opiod-Related Disorders
- Being tested
- Group ( L): LICOCAINE, GROUP Dexmedetomidine, Group M: Magnesium sulphate
- Keywords
- Intraoperative Infusion of Dexmedetomidine versus Lidocaine or Magnesium Sulphate for Enhanced Quality of Recovery After, Spine Surgery Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ( L): LICOCAINEDrug
the patient will receive lidocaine IV infusion, loading dose (1.5 mg) diluted in 10 cm 0.9% saline given bolus then (1.5-2 mg/kg/h) will start after induction of anesthesia until the end of surgery.
GROUP DexmedetomidineDrug
the patient will receive Dexmedetomidine IV infusion, loading dose (0.5 -1 mcg/kg) diluted in 10 cm 0.9% saline given bolus then (0.2-0.7mcg/kg/h) will start after induction of anesthesia until the end of surgery.
Group M: Magnesium sulphateDrug
the patient will receive Magnesium sulphate IV infusion, loading dose (30 mg/kg diluted in 10 cm 0.9% saline over 10-30 min than 6-20 mg/kg/h) will start after induction of anesthesia until the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group (L) LIDOCAINE | Active comparator | the patient will receive lidocaine IV infusion, loading dose (1.5 mg) diluted in 10 cm 0.9% saline given bolus then (1.5-2 mg/kg/h) will start after induction of anesthesia until the end of surgery. Receives: Drug: Group ( L): LICOCAINE |
| Group (D) | Active comparator | the patient will receive Dexmedetomidine IV infusion, loading dose (0.5 -1 mcg/kg) diluted in 10 cm 0.9% saline given bolus then (0.2-0.7mcg/kg/h) will start after induction of anesthesia until the end of surgery. Receives: Drug: GROUP Dexmedetomidine |
| Group (M) | Active comparator | the patient will receive Magnesium sulphate IV infusion, loading dose (30 mg/kg diluted in 10 cm 0.9% saline over 10-30 min than 6-20 mg/kg/h) will start after induction of anesthesia until the end of surgery. Receives: Drug: Group M: Magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery-40 score measured at 24 hours postoperatively
Quality of Recovery-40 contains 40 questions grouped into 5 dimensions:
- Physical Comfort (12 items)
- Emotional State (9 items)
- Physical Independence (5 items)
- Psychological Support (7 items) Scoring
Each item is scored on a 5-point Likert scale:
- = None of the time
- = Some of the time
- = Usually
- = Most of the time
- = All of the time Total score range: 40-200
- 150-200 --- excellent recovery
- 140-159 --- good recovery
- Less than 140 --- moderate recovery
Measured: 24 hours postoperatively
Secondary outcomes (1)
visual analogue scale
pain intensity using visual analogue score after surgery by scale from 0 to 10 which 0 mean no pain and 10 mean maximium pain intensity
Measured: at 2,4,6,8,12,24,48 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 posted28 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Opioid Free AnesthesiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Asmaa Mohammed Galal El-Deen, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843953
- Sponsor's protocol ID
- Zagazig M
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: planned after the completion of the study publication
Publications
Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
PubMed 4835444Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
PubMed 10740540Almajed A, Aleissa S, Al Harbi A, AlQahtani BE, Alshehri A, Alhandi AA, Alhadlaq A, Abaalkhail M, Alhelal F. The Effects of Magnesium Sulfate on Postoperative Pain in Patients Undergoing Lumbar Spinal Surgery: A Systematic Review of Randomized Controlled Trials. Cureus. 2025 Jan 12;17(1):e77352. doi: 10.7759/cureus.77352. eCollection 2025 Jan.
PubMed 39944433Dahake JS, Verma N, Bawiskar D. Magnesium Sulfate and Its Versatility in Anesthesia: A Comprehensive Review. Cureus. 2024 Mar 17;16(3):e56348. doi: 10.7759/cureus.56348. eCollection 2024 Mar.
PubMed 38633961Foo I, Macfarlane AJR, Srivastava D, Bhaskar A, Barker H, Knaggs R, Eipe N, Smith AF. The use of intravenous lidocaine for postoperative pain and recovery: international consensus statement on efficacy and safety. Anaesthesia. 2021 Feb;76(2):238-250. doi: 10.1111/anae.15270. Epub 2020 Nov 3.
PubMed 33141959Chu R, Umukoro N, Greer T, Roberts J, Adekoya P, Odonkor CA, Hagedorn JM, Olatoye D, Urits I, Orhurhu MS, Umukoro P, Viswanath O, Hasoon J, Kaye AD, Orhurhu V. Intravenous Lidocaine Infusion for the Management of Early Postoperative Pain: A Comprehensive Review of Controlled Trials. Psychopharmacol Bull. 2020 Oct 15;50(4 Suppl 1):216-259. doi: 10.64719/pb.4391.
PubMed 33633427Afrati SR, Lianou I, Kaspiris A, Marougklianis V, Kotanidou A, Pneumaticos SG. Analgesic and Neuroprotective Roles of Dexmedetomidine in Spine Surgery: A Systematic Review. Diseases. 2025 Jul 6;13(7):212. doi: 10.3390/diseases13070212.
PubMed 4071000239491750