Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400355
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-21
Brief Title:
Effect of Mannitol on Recovery Pattern After Orthognathic Surgery
Sponsor:
National Cancer Institute Egypt
Organization:
National Cancer Institute Egypt
Study Overview
Official Title:
Effect of Mannitol on Recovery Pattern After Orthognathic Surgery a Prospective Randomized Double Blind Controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
The aim of this study is to test whether mannitol infusion in different doses will affect recovery pattern the investigators hypothesized that infusion of mannitol in doses of 05 gmkg before recovery from anesthesia after orthognathic surgery shortens patients recovery time and improves recovery quality as well as postoperative cognitive function better
Detailed Description:
The aim of this study is to test whether mannitol infusion in different doses will affect recovery pattern the investigators hypothesized that infusion of mannitol in doses of 05 gmkg before recovery from anesthesia after orthognathic surgery shortens patients recovery time and improves recovery quality as well as postoperative cognitive function better Methodology This prospective randomized double blinded study will be applied on patients scheduled for orthognathic surgeries as Temporo-mandibular joint procedures Le Forte Ι 0r II osteotomy bimax or maxillectomy after ethical committee approval
The selected patients were randomly allocated into two groups each containing 30 patients
Group M in which mannitol will be given in doses of 05 gmkg 30 minutes before the end of the surgery
Group C similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery
Anaesthetic technique
For all Patients atropine sulphate 0015 mgkg intramuscular IM as anti-sialgogue together with dexamethasone 8 mg Hydrocortisone 100 mg and ranitidine 50 mg will be given IV as pre-medications 15-30 minutes before induction of anaesthesia patient will be transferred to the operating theatre where ASA-basic monitors will be applied to the patient pulse-oxymitery non-invasive blood pressure ECG 3-Leads and capnography
Induction of anesthesia
Regular IV induction will be applied for patients with normal mouth opening where difficult intubation is not suspected fentanyl 2 μgkg IV propofol 1 mgkg IV atracurium 05 mgkg IV then nasotracheal intubation with armored tube of appropriate size
Patients with difficult mouth opening will undergo awake fiberoptic intubation Anesthesia will be maintained by 100 O2 1-15 MAC isoflurane Thirty minutes before the end of surgery patients will receive an IV solution which is either mannitol 05 gmkg or lactated Ringer
The selected patients were randomly allocated into two groups each containing 30 patients
Group M in which mannitol will be given in doses of 05 gmkg 30 minutes before the end of the surgery
Group C similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery
Anaesthetic technique
For all Patients atropine sulphate 0015 mgkg intramuscular IM as anti-sialgogue together with dexamethasone 8 mg Hydrocortisone 100 mg and ranitidine 50 mg will be given IV as pre-medications 15-30 minutes before induction of anaesthesia patient will be transferred to the operating theatre where ASA-basic monitors will be applied to the patient pulse-oxymitery non-invasive blood pressure ECG 3-Leads and capnography
Induction of anesthesia
Regular IV induction will be applied for patients with normal mouth opening where difficult intubation is not suspected fentanyl 2 μgkg IV propofol 1 mgkg IV atracurium 05 mgkg IV then nasotracheal intubation with armored tube of appropriate size
Patients with difficult mouth opening will undergo awake fiberoptic intubation Anesthesia will be maintained by 100 O2 1-15 MAC isoflurane Thirty minutes before the end of surgery patients will receive an IV solution which is either mannitol 05 gmkg or lactated Ringer
Study Oversight
Has Oversight DMC:
None
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?:
None