Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Cancer Institute, Egypt

About this trial

The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 60 years.

Both sexes.

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

Height between 150-185 cm.

Disqualifiers

Allergy to any of the investigated drugs.

History of heart block, arrhythmia, or ongoing therapy with beta- or calcium channel- blockers, or angiotensin-converting-enzyme inhibitors.

Contraindications to spinal anesthesia.

Pregnancy or lactation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fentanyl + Dexmedetomidine

    Drug

    Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.

  • Fentanyl

    Drug

    Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Group DFExperimental treatment 1 intervention
Group B: Group FActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to first rescue analgesia

Time to first rescue analgesia (time from the end of surgery till the first dose of morphine is administered).

Time frame
24 hours postoperatively

Secondary outcomes

1

Total amount of morphine

If the Visual Analogue Scale (VAS) exceeded 3, rescue analgesia (RA) will be administered with intravenous morphine 3 mg.

Time frame
24 hours postoperatively
2

Intraoperative fentanyl consumption

Additional fentanyl bolus dosages of 0.5 µg/kg IV will be administered if heart rate or mean arterial blood pressure is elevated more than 20% of the baseline (after exclusion of other causes than pain).

Time frame
Intraoperatively
3

Degree of pain

Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at the Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 18, and 24 h postoperatively.

Time frame
24 hours postoperatively
4

Incidence of adverse events

Incidence of adverse events such as Nausea and vomiting, shivering, bradycardia, hypotension, and respiratory depression were recorded.

Time frame
24 hours postoperatively

Other outcomes

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