Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

Mansoura University60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Analgesia

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The post-operative analgesic duration

Time frame: during the first 24 postoperative hours

Secondary Outcomes

Onset of sensory block

from intrathecal injection till sensory block grade 2 at T10

Time frame: After intrathecal injection up to 15 minutes

Onset of motor block

from intrathecal injection till reach Bromage scale 3

Time frame: After intrathecal injection up to 15 minutes

Heart rate (HR)

beat per minute

Time frame: 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)

mmHg

Time frame: 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)

mmHg

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

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

beat per minute

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

postoperative pain

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

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

side effects as Vomiting, Nausea, pruritus, shivering

incidence

Time frame: Intraoperatively and for the first 24 hours postoperatively

sedation

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