Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

Mansoura University

Status: Completed

Conditions: Analgesia

Treatments: Drug: Nalbuphine; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05347173

Dexmed+Nalbuph

Details and patient eligibility

About

Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgical procedures. Over years many drugs have been used as an additive to spinal anesthesia in order to prolong the duration of action and to provide adequate postoperative analgesia.

Dexmedetomidine, a highly selective α2 agonist is rapidly emerging as the choice of additive to spinal anesthesia in view of its property to provide analgesia however, it may be associated with bradycardia which may affect the hemodynamic stability.

Nalbuphine is an opioid with agonist actions in the kappa receptor and antagonist actions in the mu receptor, it produces analgesia and sedation and lesser side effects through antagonism at the mu receptor but, it could be associated with some side effects as: dizziness, bradycardia, nausea, vomiting, and pruritus and may be associated with respiratory depression.

Full description

This prospective, double blinded, randomized, controlled study will be held to compare Nalbuphine versus Dexmedetomidine as adjuvants to intrathecal Bupivacaine in spinal anesthesia in patients undergoing lower limb orthopedic surgeries

Enrollment: 60 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 20 and 60 years.
• Both genders.
• Patients scheduled for lower limb orthopedic surgeries under spinal anesthesia.
• American society of anesthesiologists (ASA) class I or II.

Exclusion criteria

• Patient refusal.
• Age <20 or >60 years.
• Contraindications to spinal anesthesia (e.g. bleeding diathesis, spinal cord deformities, infection at injection site).
• History of allergy to any of the study medications.
• Cases with severe cardiac, renal, or hepatic disease.
• American society of anesthesiologists (ASA) class III, IV.
• Patient on regular analgesics or opioid abuse.
• Patient with peripheral neuropathy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Bupivacaine group (B gp)

No Intervention group

Description:

Patients will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus 0.5 ml normal saline

Bupivacaine-Dexmedetomidine group (BD gp)

Active Comparator group

Description:

Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 10 µg Dexmedetomidine in 0.5 mL normal saline

Treatment:

Drug: Dexmedetomidine

Bupivacaine-Nalbuphine group (BN gp)

Active Comparator group

Description:

Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 1 mg Nalbuphine in 0.5 mL normal saline

Treatment:

Drug: Nalbuphine