Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorTanta University

About this trial

This study aims to compare the effect of intraoperative infusion of either lidocaine or dexmedetomidine on the incidence of postoperative delirium (POD) in elderly patients undergoing major surgeries. It also aims to evaluate the impact of both medications on intraoperative regional cerebral oxygen saturation (rSO₂).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 65years old.

Both sexes.

Physical status classification of II - III according to the American Society of Anesthesiologists (ASA).

Undergo elective non-cardiac surgeries.

Disqualifiers

History of mental illness, neurological illness, or scoring less than 8 using the abbreviated mental test (AMT) before operation.

Severe hearing or visual impairment that may interfere with communication.

Severe renal or hepatic dysfunction.

Patients on central nervous system (CNS) medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine

    Drug

    Patients will receive an IV bolus (50 ml) of lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. This will be followed by intraoperative lidocaine infusion in a dose of 1.5mg /kg/hr till the end of surgery.

  • Dexmedetomidine

    Drug

    Patients will receive an IV bolus (50 ml) of dexmedetomidine in dose 0.5 μg/kg over 10 min before induction of anesthesia. This will be followed by intraoperative dexmedetomidine infusion in a dose of 0.3 μg/kg/hr till the end of surgery.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Lidocaine groupExperimental treatment 1 intervention
Group B: Dexmedetomidine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of postoperative delirium

Incidence of postoperative delirium (POD) will be recorded.

Time frame
Three days after surgery

Secondary outcomes

1

Regional cerebral oxygen saturation

Regional cerebral oxygen saturation (rScO2) will be recorded using cerebral oximetry at the baseline, 5 min after induction of general anesthesia, then every 20 min till the end of surgery.

Time frame
Till end of surgery (Up to 2 hours)
2

Degree of pain

Postoperative numerical rate scale (NRS) score will be recorded on admission to the post-anesthesia care unit (PACU), at six h, 12h, and 24h postoperatively.

Time frame
24 hours postoperatively
3

Postoperative opioid consumption

Rescue analgesia in the from 3 mg IV morphine (mg) will be given if the numerical rate scale (NRS) is ≥ 4 repeated with 10 10-minute lock-out interval till the NRS becomes less than 3.

Time frame
24 hours postoperatively
4

Heart rate

Heart rate will be recorded at baseline, after induction, after 15 min, then every 15 min till the end of surgery.

Time frame
Till end of surgery (Up to 2 hours)

Other outcomes

Sponsors and contacts

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