Pituitary Adenoma
Conditions
Keywords
Anesthesia, Transsphenoidal surgery, Enhanced recovery after surgery
Brief summary
Currently, total intravenous anesthesia (TIVA) and inhaled anesthesia are both commonly used for transsphenoidal pituitary adenoma resection. However, optimal choice for anesthesia maintenance in transsphenoidal surgery remains unclear. Previous studies focusing on this question provided fragmentary assessment and controversial results. The goal of this clinical trial is to investigate whether propofol and sevoflurane have different effect on post-anesthetic recovery after transsphenoidal resection of pituitary adenoma.
Interventions
DRUGsevoflurane
Anesthesia is maintained with inhalation of sevoflurane. The concentration of sevoflurane was adjusted to maintain anesthetic depth, aiming for a bispectral index of 40-60.
DRUGpropofol
Anesthesia is maintained with an effect-site target-controlled infusion of propofol (2-6ug/ml) based on the Marsh mode. The concentration of propofol was adjusted to maintain anesthetic depth, aiming for a bispectral index of 40-60.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women, aged from 18 to 70 2. American Society of Anesthesiologists (ASA) class I - III 3. Patients scheduled for transsphenoidal surgery requiring general anesthesia managed with endotracheal intubation
Exclusion criteria
1. Patients allergic or contraindicated to sevoflurane, propofol, or other drugs used during surgery 2. Severe pulmonary disease, saturation of peripheral oxygen (SpO2) \< 90% 3. Severe nervous system disease with consciousness disorder 4. Patients scheduled for intensive care unit (ICU) after surgery 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 15-item quality of recovery score (QoR-15) | 24 hours after end of surgery | The QoR-15 score ranges from 0 to 150 (higher is better). The investigators record the scores of two groups 1 day after the surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agitation or sedation level during emergence | From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes | The highest Richmond agitation and sedation scale score (RASS) during emergence. The RASS score ranges from -5 to +4, and a lower score indicates a more sedative level. |
| PACU antiemetic drug use | From admit into PACU to discharge from PACU, approximately 45 minutes | The drug use due to postoperative nausea and vomiting in PACU. |
| Concentration of serum adrenocorticotropic hormone (ACTH) | 24 hours after end of surgery | The investigators examine the serum level of ACTH in pg/mL. |
| Concentration of serum cortisol | 24 hours after end of surgery | The investigators examine the serum level of cortisol in ug/dL. |
| Concentration of serum thyroid-stimulating hormone (TSH) | 24 hours after end of surgery | The investigators examine the serum level of TSH in uIU/mL. |
| Concentration of serum growth hormone (GH) | 24 hours after end of surgery | The investigators examine the serum level of GH in ng/mL. |
| Concentration of serum gonadotrophin | 24 hours after end of surgery | The investigators examine the serum level of gonadotrophin in IU/L. |
| Concentration of serum prolactin (PRL) | 24 hours after end of surgery | The investigators examine the serum level of PRL ng/mL. |
| Counts of peripheral blood lymphocyte | 24 hours after end of surgery | — |
| Incidence of hypotension during anesthesia | From start of surgery to end of surgery, on an average of 2 hours | Hypotension is defined as decrease of mean arterial pressure (MAP) more than 20% of baseline. |
| Incidence of hypertension during anesthesia | From start of surgery to end of surgery, on an average of 2 hours | Hypertension is defined as increase of MAP more than 20% of baseline. |
| Time to discharge from hospital | From end of surgery to discharge from hospital, on an average of 2 days | The time between end of surgery and discharge from hospital. |
| PACU analgesic drug use | From admit into PACU to discharge from PACU, approximately 45 minutes | The drug use due to postoperative pain in PACU. |
| Post operative nausea and vomiting score | 24 hours after end of surgery | Score: 0, no nausea and vomiting; 1-4, mild nausea and vomiting; 5-6, moderate nausea and vomiting; 7-10, severe nausea and vomiting. |
| Time to awake from anesthesia | From stopping sevoflurane or propofol to awake, approximately 30 minutes | The time between discontinuing drugs and response to verbal command. |
| Time to extubation | From stopping sevoflurane or propofol to recovery of spontaneous breathing and withdrawal of tracheal tube, approximately 30 minutes | The time between discontinuing drugs and withdrawal of tracheal tube. |
| Coughing and bucking during emergence | From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes | Coughing score ranges from 0 to 3, and a higher score indicates a severer outcome.The investigators record the highest coughing score during emergence. |
| Time to discharge from postanesthesia care unit (PACU) | From admit into PACU to discharge from PACU, approximately 45 minutes | The time between admission into PACU and discharging from PACU with Aldrete score over 9. Aldrete score ranges from 0 to 10, and a higher score indicates a better recovery from anesthesia. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post operative nausea and vomiting score at postoperative day 7 | 7 days after the surgery | Score: 0, no nausea and vomiting; 1-4, mild nausea and vomiting; 5-6, moderate nausea and vomiting; 7-10, severe nausea and vomiting. |
| Sleep quality score at postoperative day 7 | 7 days after the surgery | The investigators record the sleep quality score (0 to 10, higher the better) of patients on the 7th day after the surgery by telephone follow-up. |
| Appetite score at postoperative day 7 | 7 days after the surgery | The investigators record the appetite score (0 to 10, higher the better) of patients on the 7th day after the surgery by telephone follow-up. |
| 30-day readmission | At the 1st postoperative month | The investigators record the patients' readmission to our hospital due to any pathological reason (to outpatient or inpatient). |
| Concentration of serum cortisol | At the 3rd postoperative month | The investigators examine the serum level of cortisol in ug/dL. |
| Concentration of serum growth hormone (GH) | At the 3rd postoperative month | The investigators examine the serum level of GH in ng/mL. |
| Concentration of serum gonadotrophin | At the 3rd postoperative month | The investigators examine the serum level of gonadotrophin in IU/L. |
| Concentration of serum thyroid-stimulating hormone (TSH) | At the 3rd postoperative month | The investigators examine the serum level of TSH in uIU/mL. |
| Concentration of serum prolactin (PRL) | At the 3rd postoperative month | The investigators examine the serum level of PRL ng/mL. |
| Number of participants with postoperative complications | After the surgery till discharge | The investigators record major postoperative complications and other complications related to anesthesia not mentioned above. |
| Numerical rating scale (NRS) pain score at postoperative day 7 | 7 days after the surgery | The investigators record NRS pain score (0 to 10, higher the more painful) of patients on the 7th day after the surgery by telephone follow-up. |
Countries
China
Outcome results
None listed