ONSD According to the Position During Laparoscopy

Not Applicable

Completed

• Conditions: Ovarian Cyst; Ovarian Cancer; Cervical Cancer; Cholecystitis; Uterine Myoma
• Interventions: Drug: Desflurane; Drug: Remifentanil; Device: Ultrasonographic measurement of ONSD; Procedure: Mechanical ventilation; Procedure: Trendelenburg position - 30 degree; Procedure: Reverse Trendelenburg position - 30 degree

• Registration Number: NCT01937104
• Lead Sponsor: Chosun University Hospital

Brief Summary

Increase of intracerebral pressure (ICP) during laparoscopic surgery has known to be associated with positional changes. Optic nerve sheath diameter (ONSD) has correlation with ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to investigate the change of ONSD according to the positional change during laparoscopic surgery.

Detailed Description

1. Purpose There can be many physiologic changes during laparoscopic surgery. Increase of intracerebral pressure (ICP) is one of them, which has known to be associated with arterial concentration of carbon dioxide or positional changes. Changes of ICP can be measured directly by invasive method. However, optic nerve sheath diameter (ONSD) has correlation with ICP and ultrasonographic measurement of optic nerve sheath diameter (ONSD) is known to be a noninvasive and rapidly applicable technique for evaluating ICP. The aim of this study is to investigate the change of ONSD according to the positional change during laparoscopic surgery.

2. Hypothesis Changes of ONSD will be shown according to the positional change during laparoscopic surgery, and these can reflect the changes of ICP.

3. Objectives Female patients who are scheduled to undergo laparoscopic surgery, American society of anesthesiologist class (ASA) I-II, aged between 19 to 65 years, are allocated into 2 groups.

* Group 1: Laparoscopic gynecological surgery, (Trendelenburg position)

* Group 2: Laparoscopic cholecystectomy, (Reverse trendelenburg position)

4. Methods Patients are premedicated with midazolam 0.5 mg/kg before transported to the operating room. Once in the operating room, patients were monitored with electrocardiography, non invasive blood pressure, pulse oximetry (Datex-Ohmeda S/5, Planar Systems, Inc., Beaverton, OR, USA) and BIS (Aspect 2000, Aspect Medical Systems, Inc., Newton, MA, USA).

Anesthesia are induced with propofol (2mg/kg) and followed by administering rocuronium 0.6 mg/kg. After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2) using a tidal volume of 8-10 mL/kg and a respiratory rate of 10-12/min, and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Anesthesia is maintained with desflurane in addition to the continuous infusion of remifentanil. Radial arterial cannulation is done for invasive arterial blood pressure monitoring.

After induction of anesthesia, when stabilization of cardiovascular status is achieved, optic nerve sheath diameter (ONSD) is measured by ultrasonographic measurement. Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area (4 cm deep) using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values.

ONSD was measured at 7 serial time points during surgery:

1. Preinduction (prior to the induction of anesthesia in the operating room)

2. 5 minutes after induction of anesthesia

3. 5 minutes after introducing pneumoperitoneum

4. 5 minutes after positional change

5. 15 minutes after positional change

6. 30 minutes after positional change

7. 5 minutes after discontinuing pneumoperitoneum Arterial blood gas analysis is performed to evaluate the arterial carbon dioxide concentration (PaCO2) level at each time point.

5. Statistical Analysis All data are expressed as numbers (%) or mean ± standard deviation. Repeated measures ANOVA will be performed to compare the parameters at specific time points during surgery.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Female patients who are scheduled to undergo laparoscopic surgery, American society of anesthesiologist class (ASA) I-II, aged between 19 to 65 years

Exclusion Criteria

• Aged unger 18 years or over 65 years
• American society of anesthesiologist class (ASA) III-IV
• Patients with increased intracranial pressure (e.g. hydrocephalus, intracranial hemorrhage, etc.)
• Patients with opthalmologic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Mechanical ventilation	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust minimum alveolar concentration (MAC) to maintain bispectral index (BIS) between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Trendelenburg position - 30 degree
Group 1	Trendelenburg position - 30 degree	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust minimum alveolar concentration (MAC) to maintain bispectral index (BIS) between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Trendelenburg position - 30 degree
Group 1	Ultrasonographic measurement of ONSD	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust minimum alveolar concentration (MAC) to maintain bispectral index (BIS) between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Trendelenburg position - 30 degree
Group 2	Mechanical ventilation	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Reverse Trendelenburg position - 30 degree
Group 2	Reverse Trendelenburg position - 30 degree	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Reverse Trendelenburg position - 30 degree
Group 2	Ultrasonographic measurement of ONSD	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Reverse Trendelenburg position - 30 degree
Group 1	Desflurane	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust minimum alveolar concentration (MAC) to maintain bispectral index (BIS) between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Trendelenburg position - 30 degree
Group 1	Remifentanil	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust minimum alveolar concentration (MAC) to maintain bispectral index (BIS) between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Trendelenburg position - 30 degree
Group 2	Desflurane	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Reverse Trendelenburg position - 30 degree
Group 2	Remifentanil	Drug: Desflurane Anesthesia with desflurane in both Group 1 and Group 2 - adjust MAC to maintain BIS between 40-60 Drug: Remifentanil Adjuvant continuous administration - adjust effect site concentration to maintain changes of vital sign below 20% Device: Ultrasonographic measurement of ONSD Procedure/Surgery: Mechanical ventilation Maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O. Reverse Trendelenburg position - 30 degree

Primary Outcome Measures

Name	Time	Method
ONSD and PaCO2	5 minutes after introducing positional change	ONSD and PaCO2 - 5 minutes after introducing positional change

Secondary Outcome Measures

Name	Time	Method
ONSD and PaCO2	5 minutes after introducing pneumoperitoneum	ONSD and PaCO2 - 5 minutes after introducing pneumoperitoneum

Trial Locations

Locations (1)

Chosun University Hospital; 🇰🇷 Gwangju, Donggu, Korea, Republic of