Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654531
Status:
COMPLETED
Last Update Posted:
None
First Post:
2023-06-13
Brief Title:
Effect of Intravenous or Intrathecal Dexmedetomidine on Bupivacaine Spinal Block in Lower Abdominal Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study Between the Effect of Intravenous or Intrathecal Dexmedetomidine on Bupivacaine Spinal Block
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 IV group Patients in the IV group n 25 received intrathecal hyperbaric bupivacaine 15 mg together with NSS 05 ml followed by an IV bolus dose of dexmedetomidine 05 μgkg over 10 min and then an IV infusion of a maintenance dose of 05 μgkgh 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 05 Astra Zeneca UK together with 5 μg Dexmedetomidine Precedex Abbott Chicago IL USA 100 μgml diluted with normal saline solution NSS to 10 μgml followed by an NSS IV bolus and an IV infusion of maintenance volume equivalent to that of the IV group throughout the entire period of the surgery
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 IV group Patients in the IV group n 25 received intrathecal hyperbaric bupivacaine 15 mg together with NSS 05 ml followed by an IV bolus dose of dexmedetomidine 05 μgkg over 10 min and then an IV infusion of a maintenance dose of 05 μgkgh 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 05 Astra Zeneca UK together with 5 μg Dexmedetomidine Precedex Abbott Chicago IL USA 100 μgml diluted with normal saline solution NSS to 10 μgml followed by an NSS IV bolus and an IV infusion of maintenance volume equivalent to that of the IV group throughout the entire period of the surgery
Detailed Description:
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
Patient refusal
history of cardiac hepatic neurological or renal disease
BMI 30kg m2 Morbid obesity
Patients with diabetes mellitus
history of allergy to study drugs any contraindication for regional anesthesia
Coagulopathy
failed or unsatisfactory spinal block Study tools All patients will be assigned randomly into two groups group 1 the IV group Patients in the IV group n 25 received intrathecal hyperbaric bupivacaine 15 mg together with NSS 05 ml followed by an IV bolus dose of dexmedetomidine 05 μgkg over 10 min and then an IV infusion of a maintenance dose of 05 μgkgh 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 together with 5 μg Dexmedetomidine100 μgml diluted with normal saline solution NSS to 10 μgml followed by an NSS IV bolus and an IV infusion of maintenance volume equivalent to that of the IV group throughout the entire period of the surgery
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
Patient refusal
history of cardiac hepatic neurological or renal disease
BMI 30kg m2 Morbid obesity
Patients with diabetes mellitus
history of allergy to study drugs any contraindication for regional anesthesia
Coagulopathy
failed or unsatisfactory spinal block Study tools All patients will be assigned randomly into two groups group 1 the IV group Patients in the IV group n 25 received intrathecal hyperbaric bupivacaine 15 mg together with NSS 05 ml followed by an IV bolus dose of dexmedetomidine 05 μgkg over 10 min and then an IV infusion of a maintenance dose of 05 μgkgh 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 together with 5 μg Dexmedetomidine100 μgml diluted with normal saline solution NSS to 10 μgml followed by an NSS IV bolus and an IV infusion of maintenance volume equivalent to that of the IV group throughout the entire period of the surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None