Azhar University
Asyut, Assuit, 71111, Egypt
NCT Number: NCT06654531
This study is a comparative study will be carried out after approval by the Local Ethical Committee in Al-Azhar University hospital (Assiut) and after obtaining patients' written informed consent.
50 ASA physical status I-II aged 20-60 years of both sexes scheduled for lower abdominal surgery with an expected duration of 90-120 min under spinal anesthesia will be enrolled in this study
Primary outcome :
- The onset and duration of sensory and motor blockade ,Postoperative analgesic efficacy .
Secondary outcomes :
- to assess the effect on hemodynamics and postoperative analgesic requirement All patients will be assigned randomly into two groups :group 1 (the I.V group ) Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine (Marcaine 0.5%; Astra Zeneca, UK) together with 5 μg Dexmedetomidine (Precedex; Abbott; Chicago, IL, USA, 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.
Looking for future studies?
Notify Me20 year–60 year
All sexes
Interventional
Phase 2 / Phase 3
Asyut, Assuit, 71111, Egypt
Neuraxial anesthesia and analgesia provide a solid analgesic effect by inhibiting nociceptive transmission from peripheral to the central neuronal system . However, their analgesic advantages might be limited by the short life of current local anesthetics (LAs). Therefore, adjunct analgesic strategy is an alternative to prolonging the analgesic duration and decreases the potential risk of side effects by reducing the dose of LA.
This study is a comparative study will be carried out after approval by the Local Ethical Committee in Al-Azhar University hospital (Assiut) and after obtaining patients' written informed consent. inclusion criteria will be: 50 ASA physical status I-II aged 20-60 years of both sexes scheduled for lower abdominal surgery with an expected duration of 90-120 min under spinal anesthesia will be enrolled in this study. Exclusion criteria
intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Under a sterile technique, spinal anesthesia will be carried out using a 22-G Quincke spinal needle after skin infiltration with 2% lidocaine 3 ml a t the L3-L4 level, a midline approach in the sitting position, and then in the supine position.
Th e time of spinal injection will be considered time zero (T0). The I.V drug regimen will be started according to the group to which patients will be assigned.patients will receive intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine in group 2
Time frame: 15 minutes intervals for 12 hours postoperatively
duration of sensory blockade of spinal anaesthesia
Time frame: 20 minutes intervals for 12 hours postoperatively
duration of motor blockade of spinal anesthesia
Time frame: 1 hours intervals from start of operation until 12 hours postoperatively
heart rate
Time frame: every 1 hour intervals until 12 hours postoperatively
NRS 0-10 (0 = no pain, 10 = the worst pain imaginable)
Time frame: every 30 minutes intervals for 12 hours postoperatively
Ramsay sedation scale
Time frame: 1 hours intervals from start of operation until 12 hours postoperatively
Mean blood pressure
Al-Azhar University
Other
Comparative Study Between the Effect of Intravenous or Intrathecal Dexmedetomidine on Bupivacaine Spinal Block
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.
Published trials that share one or more normalized conditions with this study.
NCT06426784
Cardiovascular Diseases, Hypotension
Islamabad, Federal, Pakistan
View Trial DetailsNCT06290583
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Qina, Egypt
View Trial DetailsNCT05650008
Cardiovascular Diseases, Global Cardiac Wall Motion Dysfunction
Hershey, Pennsylvania, United States
View Trial DetailsNCT05910086
Brain Diseases, Central Nervous System Diseases
Saint-Etienne, France
View Trial Details