Neoplasms

Nervous System Diseases

All Conditions

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Micronutrients

Antineoplastic Agents

Pharmaceutical Solutions

Vitamins

Anesthetics

Vitamin A

Retinol palmitate

Ropivacaine

Anesthetics, Local

Retinol

Patients in the control group will receive general anesthesia without the nerve blocks.

Participants randomized to the SNB group will receive general anesthesia combined with SNB using 0.75% ropivacaine, which will be performed by the same attending anesthesiologist.

In the SNB group, bilateral scalp nerve blocks will performed using 20 mL of 0.75% ropivacaine after anesthesia induction. To cover the area of surgical incision and skull clamp, seven scalp nerves including the supratrochlear, supraorbital, zygomaticotemporal, auriculotemporal, lesser occipital and greater occipital nerves, are blocked bilaterally by injecting 1-2 ml of the solution using a 25-gauge needle.

scalp nerve block

Lina Yu, doctor

Patients with Supratentorial tumor undergoing craniotomy have a higher risk of postoperative pain, which will affect their postoperative quality of recovery (QoR). Although scalp nerve block (SNB) can alleviate postoperative pain, the effect on postoperative QoR in patients with supratentorial tumor undergoing craniotomy is still unclear. This study is aimed to explore the effect of SNB on postoperative QoR in this population. To explore the effect, we design a randomized controlled trial in which 84 patients with supratentorial tumor will be randomly assigned to either the SNB group or control group. The primary outcome is 15-item QoR score at 24 h after surgery. The secondary outcomes include 15-item QoR scores at 72 h after surgery, Riker Sedation-Agitation Scale, nausea and vomiting, intraoperative opioids and propofol consumption, perioperative heart rate and mean artery pressure, the duration of anesthesia and surgery, time to extubation, PACU duration, the length of postoperative days, adverse events within 72h and total medical expenses.

Effect of SNB on the QoR in Patients Undergoing Supratentorial Tumor Resection

Effect of Scalp Nerve Block on the Quality of Recovery in Patients Undergoing Supratentorial Tumor Resection

The quality of postoperative recovery is assessed by QoR-15 on the first day after operation.

The quality of postoperative recovery is assessed by QoR-15 on the third day after operation.

Pain intensity is evaluated with the numerical rating scale (0-10, 0 = no pain, 10 = unbearable pain) at 6 time points: 20 minutes after extubation, discharge from PACU, 6 hours, 12 hours, 24 hours, and 72 hours following surgery. The worst pain score during each interval is recorded.

Riker Sedation-Agitation Scale is assessed at 2 time points: 20 minutes after extubation and discharge from PACU.

Nausea and vomiting is assessed by postoperative nausea and vomiting score (0, no nausea or vomiting; 1, nausea but no vomiting; 2, vomiting once or twice; 3, vomiting on more than two occasions) at 3 time points: discharge from PACU, 24 hours, and 72 hours after operation.

Total drug dose of sufentanil, remifentanil and propofol consumption is recorded during operation and in PACU.

Mean artery pressure and heart rate are recorded at 6 time points: before anesthesia induction (T0), after placement of the skull clamp (T1), beginning of surgery (T2), end of surgery (T3), 20 minutes after extubation (T4) , and discharge from PACU (T5).

The time to critical events are recorded, including the duration of anesthesia and surgery, time to extubation, PACU duration, postoperative hospital days and so on.

Adverse events within 72 hours after operation are recorded.

The total medical expenses is recorded during hospitalization.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Analgesics

Propofol

Remifentanil

Desflurane

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Inhalation

After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.

After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil

Optional brain relaxation improves the surgeon's operating conditions and is likely to minimize the degree of retraction injury ,with the potential for providing patients with a better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation. Propofol suppresses brain metabolism, reduces cerebral blood flow, and provides satisfactory brain relaxation. Desflurane is often criticized in neurosurgery due to its cerebral vasodilation and potential to increase intracranial pressure, however, it has been found to have a little clinical significance. This study intends to compare the effects of desflurane with propofol on brain relaxation in patients with supratentorial tumors under mild hyperventilation, and to provide new clinical evidence for the use of desflurane in neurosurgical anesthesia.

To compare the effect of desflurane versus propofol combined with remifentanil anesthesia on brain relaxation in patients undergoing supratentorial tumor surgery with mild hyperventilation, and compare the emergence time and common complications during recovery.

Desflurane and Brain Relaxation in Craniotomy

Comparison of Desflurane and Propofol for Brain Relaxation in Patients Undergoing Supratentorial Craniotomy：a Randomized Controlled Study

Assessed by the neurosurgeon using a 4-point scale (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain) at the opening of the dura mater, score 1 and 2 represent satisfactory brain relaxation

from drug discontinuation to tracheal extubation

incidence of hypoxemia, hypotension, hypertension, tachycardia, bradycardia, agitation, shivering.

evaluated by Short Orientation Memory Concentration Test (SOMCT)

evaluated using a 4-point scale after bone flap removal.

assessed by quality of recovery-15 scale (QoR-15)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of SNB on the QoR in Patients Undergoing Supratentorial Tumor Resection	NCT06157359	Postoperative A... Quality of Reco... Supratentorial ... Craniotomy Scalp Nerve Blo...	scalp nerve blo...	18 Years - 65 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Desflurane and Brain Relaxation in Craniotomy	NCT04691128	Supratentorial ...	Desflurane Propofol	18 Years - 60 Years	Beijing Tiantan Hospital
Effect of SNB on the QoR in Patients Undergoing Supratentorial Tumor Resection	NCT06157359	Postoperative A... Quality of Reco... Supratentorial ... Craniotomy Scalp Nerve Blo...	scalp nerve blo...	18 Years - 65 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University

Spots Global Cancer Trial Database for supratentorial tumor