Ignite Creation Date:
2024-10-26 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502262
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-22
Brief Title:
A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl as Additives to Bupivacaine in Potts Fracture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Comparative Study of Intrathecal Dexmedetomidine and Fentanyl as Additives to Bupivacaine in Potts Fracture
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block and postoperative analgesia
Detailed Description:
The aim of this study is to compare the addition of intrathecal dexmedetomidine or fentanyl as adjuvants to hyperbaric bupivacaine in the onset and duration of sensory and motor block and postoperative analgesia All patients will be assessed preoperatively by careful history taking full physical examination and laboratory evaluation An informed written consent will be taken from every patient just before the surgery On arrival to the operating room baseline parameters such as ECG mean arterial blood pressure heart rate and oxygen saturation will be recorded Intravenous line will be inserted and IV Ringers solution will be started 500ml bolus will be given as a preload over 20 min before performing spinal anesthesia and maintenance volume of 10mlkg
For each group patients will be put in sitting position lumbar puncture will be performed under complete aseptic precautions local anesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1 at L3-L4 and A 25-G needle will be used
Group 1 Control group 20 cases patients will receive 3 ml 15mg of 05 hyperbaric bupivacaine05 ml of normal saline intrathecally
Group 2 Fentanyl group 20 cases patients will receive 3 ml 15 mg of 05 hyperbaric bupivacaine05 ml 25μg of fentanyl intrathecally
Group 3 Dexmedetomidine group 20 cases patients will receive 3 ml 15 mg of 05 hyperbaric bupivacaine05 ml 5μg of diluted dexmedetomidine intrathecally
For each group patients will be put in sitting position lumbar puncture will be performed under complete aseptic precautions local anesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1 at L3-L4 and A 25-G needle will be used
Group 1 Control group 20 cases patients will receive 3 ml 15mg of 05 hyperbaric bupivacaine05 ml of normal saline intrathecally
Group 2 Fentanyl group 20 cases patients will receive 3 ml 15 mg of 05 hyperbaric bupivacaine05 ml 25μg of fentanyl intrathecally
Group 3 Dexmedetomidine group 20 cases patients will receive 3 ml 15 mg of 05 hyperbaric bupivacaine05 ml 5μg of diluted dexmedetomidine intrathecally
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