Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries to Evaluate the Hemodynamic Stability and Onset and Duration of Motor Block of Using Intrathecal Dexmedetomidine and Fentanyl

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-60
SponsorNashwa Ahmed

About this trial

Spinal anesthesia is the most widely employed procedure for lower limb orthopedic operations, as it is very cost-effective and simple to apply. These advantages could be restricted because presently existing local anesthetic drugs had relatively short length of action. (1) Spinal anesthesia with 0.5% heavy bupivacaine (hyperbaric) is a common technique, still there was burden of its short duration of action. To overcome this issue, there was a continuous search for an ideal adjuvant.(2) Adjuvants were mostly added to local anesthetic drugs to increase their effectiveness, speedy onset, increase the period of the block, and reduce the local anesthetics dosage, thus reduction their adverse effects.(3) Such adjuvants had been beneficial in extension of analgesia along with initiation of movement though their related side effects.(4)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient aged range from 20 to 60 years

ASA 1 and 2

Patient prepared for elective lower limb orthopaedic surgeries.

Height 150-180 cm.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    patients received 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL diluted in 12.5 ml preservative-free normal saline, 0.5 ml had been withdrawn).

  • fentanyl

    Drug

    patients received 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group DActive comparator 1 intervention
Group B: Group FActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

to evaluate duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.

Duration of motor block had been evaluated by the time taken to return from complete Bromage motor block (bromage 3) to scale 0. Motor block was evaluated with Modified Bromage scale (6) Bromage 0: The patient could move the hip, knee, and ankle. Bromage 1: The patient could move the hip but had ability to move the knee and ankle. Bromage 2: The patient could move the hip and knee but had ability to move the ankle. Bromage 3: The patient could not move the hip, knee, and ankle.

Time frame
7 hour
2

evaluate onset of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.

onset time of bromage 3 motor block had been recorded (Onset of the motor block; period between the ending of intrathecal drug injection and entire motor paralysis)

Time frame
10 minutes
3

to evaluate non invasive mean blood pressure using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.

Intraoperatively non-invasive mean blood pressure had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.

Time frame
90 minutes
4

to evaluate the heart rate using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.

Intraoperatively heart rate had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.

Time frame
90 minutes

Secondary outcomes

1

Complications would be noted Intraoperative

nausea, vomiting, pruritis. Hypotension (\> 20% fall of baseline blood pressure or systolic blood pressure of \<100mmHg.) had been treated with bolus dose of 6 mg ephedrine IV Bradycardia (pulse rate \< 60 bpm), had been treated with 0.3- 0.6 mg atropine IV Incidence of respiratory depression defined as respiratory rate less than 9 /min and SpO2 less than 90% on room air, would be noted, it had been treated with Oxygen (2 L/min), administered via a mask.

Time frame
90 minutes

Other outcomes

Sponsors and contacts

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Nashwa Ahmed

Lead sponsor

Port Said University hospital

Sponsor institution