Intraoperative Infusion of Dexmedetomidine Versus Lidocaine or Magnesium Sulphate for Enhanced Quality of Recovery After Spine Surgery Fixation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZagazig University

About this trial

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.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient acceptance.

Patients age between 18-60 years old.

Disqualifiers

Uncooperative patient.

Allergy to study drugs.

Patients on chronic alcohol, opioid, tranquilizer or sedative use.

Pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group ( L): LICOCAINE

    Drug

    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 Dexmedetomidine

    Drug

    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 sulphate

    Drug

    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.

Treatment groups

117 Participants
are divided into 3 treatment groups
Group A: Group (L) LIDOCAINEActive comparator 1 intervention
Group B: Group (D)Active comparator 1 intervention
Group C: Group (M)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Recovery-40 score measured at 24 hours postoperatively

Quality of Recovery-40 contains 40 questions grouped into 5 dimensions: 1. Physical Comfort (12 items) 2. Emotional State (9 items) 3. Physical Independence (5 items) 4. Psychological Support (7 items) Scoring Each item is scored on a 5-point Likert scale: 1. = None of the time 2. = Some of the time 3. = Usually 4. = Most of the time 5. = All of the time Total score range: 40-200 * 150-200 --- excellent recovery * 140-159 --- good recovery * Less than 140 --- moderate recovery

Time frame
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

Time frame
at 2,4,6,8,12,24,48 hours after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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