Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621004
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Low Dose Magnesium Sulphate
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Low Dose Magnesium Sulphate in Nasal Surgery
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
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 clinical trial aims to compare Patients who receive propranolol 1-2 mg to Patients who receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mgkg to see if IV magnesium can stability mean arterial blood pressure and heart rate in patients undergoing nasal surgeries as well as the quality of postoperative analgesia degree of sedation mean arterial blood pressure and HR will be recorded intraoperative and Participants will be asked to rate the pain at the first second fourth sixth and 24th postoperative hour using the VAS score
Analgesic requirements The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded
Sedation score the degree of sedation will be assessed using the Ramsy sedation score
Analgesic requirements The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded
Sedation score the degree of sedation will be assessed using the Ramsy sedation score
Detailed Description:
This prospective randomized controlled clinical trial aims to establish the effect of magnesium sulphate during nasal surgery regarding deliberate hypotension postoperative analgesia and sedation with minimal side effects
this study will be conducted in the plastic surgery and ENT operating rooms at ASUH 130 patients undergoing rhinoplasty or functional endoscopic sinus surgery FESS operation under general anaesthesia
patients will be allocated into 2 groups 65 patients each using a computer-generated randomization list
Group P Patients will receive propranolol 1-2 mg Group PM Patients will receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mgkg
ABP and HR are continuously monitored and will be recorded before the start of anaesthesia T1 after intubation T2 at skin incision T3 at manipulation of nasal bones T4 at extubation T5 before discharge to PACU T6 and after 30 min in PACU
Surgical duration time from skin incision till skin closure
Extubation time from the end of anaesthesia to extubation
Modified Alderete score will be assessed and recorded every 5 minutes until discharge Patients will be discharged upon achieving an Aldrete score of 9
The time to discharge will be recorded
VAS score for pain
Analgesic requirements The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded
Sedation score the degree of sedation will be assessed using the Ramsy sedation score where all be recorded
this study will be conducted in the plastic surgery and ENT operating rooms at ASUH 130 patients undergoing rhinoplasty or functional endoscopic sinus surgery FESS operation under general anaesthesia
patients will be allocated into 2 groups 65 patients each using a computer-generated randomization list
Group P Patients will receive propranolol 1-2 mg Group PM Patients will receive propranolol 1-2 mg in addition to magnesium sulphate infusion 10 mgkg
ABP and HR are continuously monitored and will be recorded before the start of anaesthesia T1 after intubation T2 at skin incision T3 at manipulation of nasal bones T4 at extubation T5 before discharge to PACU T6 and after 30 min in PACU
Surgical duration time from skin incision till skin closure
Extubation time from the end of anaesthesia to extubation
Modified Alderete score will be assessed and recorded every 5 minutes until discharge Patients will be discharged upon achieving an Aldrete score of 9
The time to discharge will be recorded
VAS score for pain
Analgesic requirements The time to first demand analgesia and the total amount of analgesia required in the 1st 24 will be recorded
Sedation score the degree of sedation will be assessed using the Ramsy sedation score where all be recorded
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