Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

NCT05347173 | Completed

• 1 other identifier: Dexmed+Nalbuph
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• The post-operative analgesic duration

  during the first 24 postoperative hours

Secondary Outcomes (9)

• Onset of sensory block

  After intrathecal injection up to 15 minutes

• Onset of motor block

  After intrathecal injection up to 15 minutes

• Heart rate (HR)

  Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery

• Mean arterial pressure (MAP)

  Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery

• Hypotension will be considered if there was 25% decrease below the baseline for Mean arterial pressure (MAP)

  every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively

Study Arms (3)

Bupivacaine group (B gp)

NO INTERVENTION

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

Bupivacaine-Dexmedetomidine group (BD gp)

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Bupivacaine-Nalbuphine group (BN gp)

ACTIVE COMPARATOR

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

Drug: Nalbuphine

Interventions

Dexmedetomidine DRUG

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

Bupivacaine-Dexmedetomidine group (BD gp)

Nalbuphine DRUG

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

Bupivacaine-Nalbuphine group (BN gp)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University-Emergency hospital-ICU

El Dakahlia, Mansoura, 35511, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Nalbuphine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Intrathecal injectate will be prepared according to the group by an anesthesiologist who is not involved in data collection
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Model Details: Via the sealed envelope method; the patients will be randomly assigned to three equal groups according to the administration of adjuvant to intrathecal Bupivacaine and its dose; * Bupivacaine group (B gp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) +0.5 ml normal saline. * Bupivacaine-Dexmedetomidine group (BDgp) will include 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) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5ml normal saline).

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 26, 2022
• Study Start: June 21, 2022
• Primary Completion: January 30, 2024
• Study Completion: March 12, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

EG (1)