Lidocaine and Dexmedetomidine Infusions for Intraoperative Bleeding in Functional Endoscopic Sinus Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAin Shams University

About this trial

This work aims to compare lidocaine and dexmedetomidine infusions for intraoperative bleeding in patients undergoing functional endoscopic sinus surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 65 years old.

American Society of Anesthesiologists (ASA) physical status I - II.

Scheduled for elective functional endoscopic sinus surgery.

Disqualifiers

Diabetes mellitus.

Coagulation disorders.

Kidney and liver dysfunction.

Cerebrovascular disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lidocaine

    Drug

    Patients will receive lidocaine (1.5 mg/kg loading then 1mg/kg/h infusion) just after induction of anesthesia induction and continued until the end of the operation.

  • Dexmedetomidine

    Drug

    Patients will receive 1 μg/kg dexmedetomidine infusion over 10 min as a loading dose then 0.4-0.7 μg/kg/h just after induction of anesthesia induction and continued until the end of the operation.

Treatment groups

40 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

Surgical field

Surgical field will be assessed by Fromme et al. scale. (0-no bleeding, 1-slight bleeding, no suctioning of blood required, 2-slight bleeding occasional suctioning required, surgical field not threatened, 3-slight bleeding - frequent suctioning required. Bleeding threatens surgical field as few seconds after suction will be removed, 4-moderate bleeding - frequent suctioning required, bleeding threatens surgical field directly after suction will be removed, 5-severe bleeding - constant suctioning required, bleeding appeared faster than removed by suction. The surgical field severely threatened, and surgery not possible). The ideal category scale value will be determined to be ≤3.

Time frame
Intraoperatively

Secondary outcomes

1

Total morphine consumption

Rescue analgesia of morphine will be given as 3 mg bolus if the VAS \> 3 to be repeated after 30 min if pain persists until the Visual Analogue Scale (VAS)\< 4. VAS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 12, 18, and 24h postoperatively.

Time frame
24 hours postoperatively
2

Heart rate

Heart rate will be recorded before induction, every 5 minutes for the first 20 minutes, then every 15 minutes until the end of the surgery.

Time frame
Till the end of surgery (Up to 4 hours)
3

Mean arterial pressure

Mean arterial pressure will be recorded before induction, every 5 minutes for the first 20 minutes, then every 15 minutes until the end of the surgery.

Time frame
Till the end of surgery (Up to 4 hours)
4

Time to the first request for the rescue analgesia.

Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).

Time frame
24 hours postoperatively

Other outcomes

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