Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

Analgesia Clinical Trial

— Intrathecal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347173
• Other study ID #: Dexmed+Nalbuph
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 12, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Dexmedetomidine
patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 mL normal saline)
• Nalbuphine
patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5 mL normal saline)

Locations

Country	Name	City	State
Egypt	Mansoura University-Emergency hospital-ICU	El Dakahlia	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The post-operative analgesic duration		during the first 24 postoperative hours
Secondary	Onset of sensory block	from intrathecal injection till sensory block grade 2 at T10	After intrathecal injection up to 15 minutes
Secondary	Onset of motor block	from intrathecal injection till reach Bromage scale 3	After intrathecal injection up to 15 minutes
Secondary	Heart rate (HR)	beat per minute	Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
Secondary	Mean arterial pressure (MAP)	mmHg	Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery
Secondary	Hypotension will be considered if there was 25% decrease below the baseline for Mean arterial pressure (MAP)	mmHg	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
Secondary	Bradycardia will be considered if the heart rate is less than 50 beats/min	beat per minute	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
Secondary	postoperative pain	visual analogue scale (VAS) marked from 0-10 (where 0 = no pain and 10 = worst pain imaginable)	at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively
Secondary	side effects as Vomiting, Nausea, pruritus, shivering	incidence	Intraoperatively and for the first 24 hours postoperatively
Secondary	sedation	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]	at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively