NCT07389096

Brief Summary

Opioid-free anesthesia (OFA) is a multimodal analgesic approach designed to eliminate the intraoperative use of systemic, neuraxial, or intracavitary opioids. This technique employs a combination of antinociceptive agents targeting various pathways within the central and peripheral nervous systems to achieve effective analgesia. Dexmedetomidine (DEX), a highly selective α2-adrenoreceptor agonist, is a centrally acting non-opioid agent increasingly utilized in clinical practice for its antinociceptive and anxiolytic properties. Only a few prospective randomized controlled trials have specifically examined the postoperative analgesic efficacy of intraoperative dexmedetomidine infusion in patients undergoing spinal surgery, with limited data focusing on this as a primary endpoint. Importantly, no clinical studies have investigated its analgesic impact in patients undergoing spinal surgery under general anesthesia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
9mo left

Started Jan 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

December 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

December 28, 2025

Last Update Submit

January 30, 2026

Conditions

Opioid Free Anesthesia

Outcome Measures

Primary Outcomes (2)

  • intraoperative analgesic effectiveness, Measured by Heart Rate

    Changes in heart rate recorded at predefined intraoperative intervals to assess physiological response to analgesia.

    2 hours

  • intraoperative analgesic effectiveness, Measured by blood pressure

    Changes in blood pressure recorded at predefined intraoperative intervals.

    2 hours

Secondary Outcomes (5)

  • the requirement for rescue fentanyl

    24 hour

  • surgeon satisfaction

    2 hours

  • Assessment of Intraoperative Blood Loss

    2 hours

  • hemodynamics

    2 hours

  • Quality of surgical field

    2 hours

Study Arms (2)

Group OFA (Opioid-Free Anesthesia):

ACTIVE COMPARATOR
Drug: Dexmedetomidine

Group OBA (Opioid-Based Anesthesia)

ACTIVE COMPARATOR
Drug: Fentanyl (IV)

Interventions

DexmedetomidineDRUG

patients will Receive dexmedetomidine with a loading dose of 1 μg/kg followed by a maintenance infusion of 0.5 μg/kg/h.

Group OFA (Opioid-Free Anesthesia):
Fentanyl (IV)DRUG

patients will Receive fentanyl with a loading dose of 1 μg/kg followed by a maintenance infusion of 0.5 μg/kg/h.

Group OBA (Opioid-Based Anesthesia)

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Non-idiopathic scoliosis
  • Contraindications to commonly used perioperative medications
  • ASA Physical Status ≥ III
  • Presence of neuromuscular disorders or severe cardiac dysfunction
  • Requirement for postoperative mechanical ventilation
  • Regular use of analgesics or opioids
  • History of allergy to opioids or dexmedetomidine
  • Diagnosed mental disorders
  • Severe hepatic or renal dysfunction
  • Coagulopathy or significant pulmonary disease
  • Preoperative or postoperative neurological deficits
  • Occurrence of serious arrhythmia, hypotension, or bradycardia necessitating discontinuation of dexmedetomidine infusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Port said university

Port Said, 42111, Egypt

RECRUITING

Related Publications (9)

  • Aujla KS, Kaur M, Gupta R, Singh S, Bhanupreet, Tavleen. A study to compare the quality of surgical field using total intravenous anesthesia (with propofol) versus inhalational anesthesia (with isoflurane) for functional endoscopic sinus surgeries. Anesth Essays Res 2017; 11:606-10. DOI: 10.4103/0259-1162.206858

    RESULT

  • Ghorbani J, Arastou S, Naeini A, Raad N, Galougahi M, Jahangirifard A, Dilmaghani N. Comparing the Effect of Oral Clonidine and Tranexamic Acid on Bleeding and Surgical Field Quality during Functional Endoscopic Sinus Surgery. Iranian Journal of Otorhinolaryngology 2018; 30(5):255-60

    RESULT

  • Lin Y, Yu C, Xian G. Calculation methods for intraoperative blood loss: a literature review. BMC Surgery 2024; 24:394 doi.org/10.1186/s12893-024-02699-3

    RESULT

  • Pipat Saeyup, Chanon Thanaboriboon. Anesthetic Management and Role of Dexmedetomidine During Intraoperative Wake Up Test in Juvenile Idiopathic Scoliosis Correction Surgery: A Case Report. International Journal of Anesthesia and Clinical Medicine. 2019; 7(1): 27-30 Doi: 10.11648/j.ijacm.20190701.15

    RESULT

  • Soffin E, Wetmore D, BeckmanJ, Sheha E, Vaishnav A, Albert T, Gang C, Qureshi S. Opioid-free anesthesia within an enhanced recovery after surgery pathway for minimally invasive lumbar spine surgery: a retrospective matched cohort study. Neurosurg Focus 2019;46(4): E8.DOI: 10.3171/2019.1. FOCUS18645

    RESULT

  • 4- Çatalca, Sibel, Özmete, Özlem, Berk, Numan, Çivi, Soner, Durdağ, Emre, Incekaş, Caner, Özyilkan, Nesrin Bozdoğan. Does dexmedetomidine infusion reduce the postoperative analgesic need in lumbar disc surgery? Turkish Journal of Medical Sciences 2025;55: 470-481. doi.org/10.55730/1300-0144.5991

    RESULT

  • 3- Rani US, Panda NB, Chauhan R, Mahajan S, Kaloria N, Tripathi M. Comparison of the effects of opioid free anesthesia (OFA) and opioid based anesthesia (OBA) on postoperative analgesia and intraoperative hemodynamics in patients undergoing spine surgery: A prospective randomized double blind controlled trial. Saudi J Anaesth 2024; 18:173 80. DOI: 10.4103/sja.sja_341_23

    RESULT

  • 2- Moustafa A, Negmi H, Rabie M. The Combined effect of ketamine and remifentanil infusions as total intravenous anesthesia for scoliosis surgery in children. Middle East J Anaesthesiol 2008 ;19(5):1151-68.

    RESULT

  • 1- Ferschl M, Shibata G, Wong J. New Surgical Approaches to Scoliosis Repair in Pediatric Patients Implications for Anesthetic Management. Current Anesthesiology Reports 2024; 14:475-83. doi.org/10.1007/s40140-024-00641-0

    RESULT

MeSH Terms

Interventions

DexmedetomidineFentanyl

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Central Study Contacts

Nashwa gomaa Ahmed, MD

CONTACT

00201005289328dr_nashwa_2008@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
, Lecturer of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Port Said University, Egypt

Study Record Dates

First Submitted

December 28, 2025

First Posted

February 5, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)