Supratentorial Neoplasms Clinical Trial
Official title:
Hemodynamic Effects of Opioid Free Anesthesia Versus Opioid Anesthesia on Adult Patients Undergoing Craniotomies for Supratentorial Tumors. Randomized Controlled Trial
Verified date | October 2021 |
Source | Kasr El Aini Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hemodynamic control during craniotomies can be a bit hectic specially during periods of intense noxious stimulation. For long anesthesiologists used high doses of opioids such as fentanyl and remifentanyl to provide analgesia with a good hemodynamic control during intraoperative period in patients undergoing craniotomies. However, the use of opioids was not devoid of side effects. Exploring other anesthetic plans using multiple opioid free anesthetic adjuvants that have analgesic effects given together in small doses appear to be appealing plan. This idea is the basis of our proposed study in which we compare the hemodynamic effects of using opioid free anesthesia versus opioid anesthesia in cranial surgeries.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 3, 2021 |
Est. primary completion date | October 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - ASA ? and II. - Patients undergoing surgeries for removal of supratentorial tumors. - Age (18-60) years. - Both sexes. Exclusion Criteria: - Impaired renal functions. - Systemic hypertension. - Dysrhythmia. - Heart failure. - Glasgow coma scale less than 12. - The need for postoperative ventilation. - History of allergy to the study drugs. - Surgeries lasting more than 6 hours. - Pregnancy. - Bronchial asthma |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr El Aini Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Kasr El Aini Hospital |
Egypt,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients experiencing a change in mean arterial pressure at time of Burr Hole | Defined as recording an increase or decrease of the mean arterial blood pressure by more than 25 % from baseline readings at the time of burr hole | During Burr hole surgery | |
Secondary | HR (heart rate) in beats/min | Hemodynamic parameter recorded during the study | Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU. | |
Secondary | Brain relaxation score | Defined as 1= excellently relaxed, 2= satisfactory relaxed, 3= leveled, 4=bulging | At the time of dural incision | |
Secondary | Number of patients requiring antihypertensive medication | Number of patients needing nitroglycerine infusion in each group was recorded together with total amount infused | Throughout the operation | |
Secondary | Number of patients requiring medication to increase blood pressure | Number of patients needing ephedrine in each group was recorded together with total amount infused. | Throughout the operation | |
Secondary | Time to extubation | Defined as the time between the discontinuation of inhalation agents and extubation | At the end of the operation, the time from the discontinuation of inhalation agents till extubation | |
Secondary | Ramsay Sedation Scale (RSS) | to assess the postoperative sedation, it is a scale from 1 to 6. It provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (patient is cooperative, orientated and tranquil) | every 30 minutes for 2 hours postoperative | |
Secondary | Systolic blood pressure (SBP) in mmhg | Hemodynamic parameter recorded during the study | Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU. | |
Secondary | Mean arterial blood pressure (MAP) in mmhg | Hemodynamic parameter recorded during the study | Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU. |
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