Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine
- Registration Number
- NCT05347173
- Lead Sponsor
- Mansoura University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bupivacaine-Dexmedetomidine group (BD gp) Dexmedetomidine Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 10 µg Dexmedetomidine in 0.5 mL normal saline Bupivacaine-Nalbuphine group (BN gp) Nalbuphine Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 1 mg Nalbuphine in 0.5 mL normal saline
- Primary Outcome Measures
Name Time Method The post-operative analgesic duration during the first 24 postoperative hours
- Secondary Outcome Measures
Name Time Method Onset of motor block After intrathecal injection up to 15 minutes from intrathecal injection till reach Bromage scale 3
Heart rate (HR) Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery beat per minute
Onset of sensory block After intrathecal injection up to 15 minutes from intrathecal injection till sensory block grade 2 at T10
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 mmHg
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 mmHg
Bradycardia will be considered if the heart rate is less than 50 beats/min 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
postoperative pain 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)
side effects as Vomiting, Nausea, pruritus, shivering Intraoperatively and for the first 24 hours postoperatively incidence
sedation at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively via Ramsay scale \[1= Patient is anxious and agitated or restless, or both, 2= Patient is co-operative, oriented, and tranquil, 3= Patient responds to commands only, 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus and 6=Patient exhibits no response\]
Trial Locations
- Locations (1)
Mansoura University-Emergency hospital-ICU
🇪🇬El Dakahlia, Mansoura, Egypt