Skip to main content
OpenTrials
Completed

NCT Number: NCT05347173

Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University-Emergency hospital-ICU

El Dakahlia, Mansoura, 35511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Nalbuphine

Drug

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

Primary outcomes

  1. The post-operative analgesic duration

    Time frame: during the first 24 postoperative hours

Secondary outcomes

  1. Onset of sensory block

    Time frame: After intrathecal injection up to 15 minutes

    from intrathecal injection till sensory block grade 2 at T10

  2. Onset of motor block

    Time frame: After intrathecal injection up to 15 minutes

    from intrathecal injection till reach Bromage scale 3

  3. Heart rate (HR)

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

    beat per minute

  4. Mean arterial pressure (MAP)

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

    mmHg

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

    Time frame: 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

    mmHg

  6. Bradycardia will be considered if the heart rate is less than 50 beats/min

    Time frame: 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

    beat per minute

  7. postoperative pain

    Time frame: at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively

    visual analogue scale (VAS) marked from 0-10 (where 0 = no pain and 10 = worst pain imaginable)

  8. side effects as Vomiting, Nausea, pruritus, shivering

    Time frame: Intraoperatively and for the first 24 hours postoperatively

    incidence

  9. sedation

    Time frame: at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively

    via Ramsay scale [1= Patient is anxious and agitated or restless, or both, 2= Patient is co-operative, oriented, and tranquil, 3= Patient responds to commands only, 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus and 6=Patient exhibits no response]

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine in Lower Limb Surgeries

Acronym: Intrathecal

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2022
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.