Sevoflurane With or Without Intravenous Lidocaine Infusion Versus Propofol Anesthesia on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Hysterectomy

Tanta University

Status: Enrolling

Conditions: Intracranial Pressure; Propofol; Laparoscopic Hysterectomy; Lidocaine; Sevoflurane; Cerebral Oxygenation

Treatments: Drug: Sevoflurane plus lidocaine infusion; Drug: Propofol; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT07062367

36265MD329/12/24

Details and patient eligibility

About

This study will be conducted to evaluate the effects of different anesthetic modalities [sevoflurane with or without intraoperative lidocaine infusion and Propofol total intravenous anesthesia (TIVA)] on intracranial pressure (ICP) and cerebral oxygenation assessed by non-invasive methods during laparoscopic hysterectomy (LH).

Full description

Laparoscopic hysterectomy (LH) requires a Trendelenburg position (TP) and the creation of an artificial pneumoperitoneum (PP) by carbon dioxide insufflation.

Various studies were done to evaluate the effects of different anesthesia techniques on intracranial pressure (ICP) during LH, and most of these studies revealed that propofol total intravenous anesthesia (TIVA) was superior to inhaled anesthesia regarding reduction of ICP (ONSD).

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 65 years.
• American Society of Anesthesiologists (ASA) physical status I and Ⅱ.
• Body mass index (BMI) ≤35.
• Females scheduled for laparoscopic hysterectomy.

Exclusion criteria

• Patients' refusal to participate in the study.
• Hypersensitivity and allergy to drugs of the study.
• Contraindication for optic nerve sheath diameter assessment. E.g., patient with pre-existing ophthalmic diseases, a history of ophthalmic surgery
• Any central nervous system or cardiovascular disease, severe hepatic or renal impairment
• Intraoperative circumstances, such as inability to perform optic nerve sheath diameter or conversion to open surgery
• If peak inspiratory pressure (PIP) exceeds 35.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

Propofol group

Active Comparator group

Description:

Patients' anesthesia will be maintained by manually adjusted propofol infusion at a rate of 100-250 mic/kg/min for bispectral index (BIS) maintained between 40-60.

Treatment:

Drug: Propofol

Sevoflurane plus lidocaine infusion group

Experimental group

Description:

Sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60 plus intravenous lidocaine infusion given as 2mg /kg IV bolus before induction then intraoperative infusion by a rate of 2 mg/kg/h until the end of surgery.

Treatment:

Drug: Sevoflurane plus lidocaine infusion

Sevoflurane group

Experimental group

Description:

Patients will receive sevoflurane with monitored anesthesia care (MAC) adjusted to maintain bispectral index (BIS) between 40-60.

Treatment:

Drug: Sevoflurane