Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-27 @ 1:56 PM
Study NCT ID:
NCT05369468
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2022-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmetomidine With Erector Spinae Plane Block in Cholecystectomy
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Efficacy of Adding Dexmedetomidine to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sixty patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned using sealed envelope into two equal groups (30 patients each).
Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .
Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .
Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .
Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .
Detailed Description:
This prospective randomized study will be carried out in general surgery Department within 6 months from January 2022 to June 2022 on the 60 patients scheduled for elective laparoscopic cholecystectomy . A written informed consent will be obtained from the patients. Every patient will receive an explanation to the purpose of the study and will have a secret code number and the photos applied only to the part of the body linked to the research to ensure privacy to participants and confidentiality of data.
Research results will be only used for scientific purposes. Procedures will be approved by both the Institutional and the Regional ethical committees.
The risk that may occur is minimal, inadequate analgesia and this risk will be overcome by tramadol 50 mg intravenously STAT dose. Any unexpected risk appears during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken to overcome or minimize these risks.
The research end point when reach desired lower pain score postoperative without occurance of any complication as heamodynamic instability.
. Preanesthetic checkup and routine investigations, such as complete blood count test, liver \&kidney function test and coagulation profile, will be done. Patients will be kept fasting for 8 h.
On arrival in the operative room, standard monitoring equipment will be attached (electrocardiogram, pulse oximeter, and noninvasive blood pressure) and baseline vital parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), and oxygen saturation (SpO2) will be noted just before induction of anesthesia. Peripheral venous access will be obtained IV crystalloid at rate 10 ml\\kg will be infused.
Technique of ultrasound guided Erector spine plane block:
The pa¬tient will be placed in sitting position and the ultrasound-guided ESP block was performed bilaterally at the (T7) level. A 23 G spinal needle was inserted with the bevel in cephalo- caudal direction .
Sixty patients will be randomly assigned using sealed envelope into two equal groups (30 patients each).
Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .
Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .
Anesthesia will be induced with injection of propofol 2 mg/kg, and fentanyl 1ug/kg intravenous (I.V) Endotracheal intubation will be facilitated with injection rocuronium bromide 0.9 mg/kg IV. Anesthesia will be maintained with in O2 with sevoflurane 2% to maintained BIS 40-60. Neuromuscular relaxation will be maintained with injection rocuronium top ups of 0.3 mg i.v every hour.
The lungs will be mechanically ventilated to keep end-tidalCO2 within normal range and residual neuromuscular block will be reversed with injection neostigmine (0.05 mg/kg) and injection atropine (0.01 mg/kg). The patients will be extubated when respiration deemed sufficient. The patients will be transferred to recovery room. In the post anesthesia care unit(PACU), they will be monitored for any evidence of complications or adverse events and discharged when aldert score ≥ 9.
Research results will be only used for scientific purposes. Procedures will be approved by both the Institutional and the Regional ethical committees.
The risk that may occur is minimal, inadequate analgesia and this risk will be overcome by tramadol 50 mg intravenously STAT dose. Any unexpected risk appears during the course of the research will be cleared to the participants and ethical committee on time and proper measures will be taken to overcome or minimize these risks.
The research end point when reach desired lower pain score postoperative without occurance of any complication as heamodynamic instability.
. Preanesthetic checkup and routine investigations, such as complete blood count test, liver \&kidney function test and coagulation profile, will be done. Patients will be kept fasting for 8 h.
On arrival in the operative room, standard monitoring equipment will be attached (electrocardiogram, pulse oximeter, and noninvasive blood pressure) and baseline vital parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), and oxygen saturation (SpO2) will be noted just before induction of anesthesia. Peripheral venous access will be obtained IV crystalloid at rate 10 ml\\kg will be infused.
Technique of ultrasound guided Erector spine plane block:
The pa¬tient will be placed in sitting position and the ultrasound-guided ESP block was performed bilaterally at the (T7) level. A 23 G spinal needle was inserted with the bevel in cephalo- caudal direction .
Sixty patients will be randomly assigned using sealed envelope into two equal groups (30 patients each).
Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .
Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .
Anesthesia will be induced with injection of propofol 2 mg/kg, and fentanyl 1ug/kg intravenous (I.V) Endotracheal intubation will be facilitated with injection rocuronium bromide 0.9 mg/kg IV. Anesthesia will be maintained with in O2 with sevoflurane 2% to maintained BIS 40-60. Neuromuscular relaxation will be maintained with injection rocuronium top ups of 0.3 mg i.v every hour.
The lungs will be mechanically ventilated to keep end-tidalCO2 within normal range and residual neuromuscular block will be reversed with injection neostigmine (0.05 mg/kg) and injection atropine (0.01 mg/kg). The patients will be extubated when respiration deemed sufficient. The patients will be transferred to recovery room. In the post anesthesia care unit(PACU), they will be monitored for any evidence of complications or adverse events and discharged when aldert score ≥ 9.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: