Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

NCT ID: NCT05347173

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2024-03-12

Brief Summary

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.

Detailed 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

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine group (B gp)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Bupivacaine-Dexmedetomidine group (BD gp)

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Bupivacaine-Nalbuphine group (BN gp)

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

Group Type: ACTIVE_COMPARATOR

Nalbuphine

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

Nalbuphine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

maha abou-zeid

Assistant Professor of Anesthesia and Surgical Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University-Emergency hospital-ICU

El Dakahlia, Mansoura, Egypt

Countries

Egypt

Other Identifiers

Dexmed+Nalbuph

Identifier Type: -

Identifier Source: org_study_id