Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05146232 |
| Other study ID # |
34777/7/21 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 5, 2022 |
| Est. completion date |
March 30, 2022 |
Study information
| Verified date |
December 2021 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Obesity and pneumoperitoneum in the reverse-Trendelenburg position during laparoscopic sleeve
gastrectomy (LSG) are reported to negatively affect cerebral oxygenation. Anesthetic agents
can have variable effects on the regional cerebral tissue oxygen saturation (rSO2) measured
with near-infrared spectroscopy. This study investigated the potential impact of opioid free
versus opioid based anesthesia on rSO2 in LSG cases. 80 American Society of Anesthesiologists
(ASA) II-III patients, 18-65 years of age, with a body mass index of >35 kg/m2 , undergoing
LSG were randomized to two groups: opioid free and opioid based groups for anesthesia
maintenance. The rSO2 values were recorded preoperatively, 1 min after anesthesia induction,
and every 5 min during surgery. Arterial blood gases (ABG) were measured in the fifth minute
postinduction (t1), 30th minute postinsuflation (t2), and postextubation (t3), and
correlation with rSO2 .
Description:
All study participants wiere provided a written informed consent before enrollment. 80
patients in the American Society of Anesthesiologists (ASA) physical status class II-III,
18-65 years of age, with a BMI of >35 kg/m2 who were planning to undergo an elective LSG were
enrolled in the study. Patients with preexisting cerebrovascular diseases, overt neurological
signs, alcohol or psychoactive drug addiction, uncontrolled diabetes or hypertension,
advanced organ failure, preoperative peripheral oxygen saturation (SpO2) <96%, or a
hemoglobin˂9g/dL were excluded.
Randomization for the investigation, the patients were randomly assigned using opaque sealed
envelopes to two groups; Group (I) (n = 40): The Opioid based anesthesia: Pre-induction of
general anesthesia a bolus of 2ug/kg/ IV Fentanyl (sunny pharmaceutical Egypt Company under
License of Hameln pharmaceutical Germany) was administered then infusion of 1 ug/kg/h was
given intraoperatively to maintain the change in hemodynamics within 20 % of the baseline ,
and Group (II) (n = 40): Opioid free anesthesia: Pre-induction of general anesthesia 1000 mg
paracetamol (Pharco B international pharmaceutical-Egypt) and dexamethasone 0.1 mg/kg.
Lidocaine 1 mg/kg (Alexandria co. for pharmaceutical and chemical industries-Egypt), ketamine
0.5 mg/kg were given I V bolus dose. Then continuous infusion with lidocaine 2 mg/kg/hr and
magnesium sulfate (Manufactured by E.I.P.I.CO-. Egypt).1.5 g/hr was started. Local
infiltration of skin incision with 0.25% bupivacaine at the end of the operation (Sunny
pharmaceutical -Egypt) (n = 30). Randomization was performed according to a
computer-generated randomization code, and a statement showing the patients' group was placed
in a sealed, numbered envelope according to the results. Each patient drew an envelope and
was enrolled in the study depending on the group written in the envelope. Randomization was
performed by a physician who was not involved in the monitoring of the patients. The
anesthesiologist caring for the patient was aware of the group assignments. The patients were
blinded to the group assignments.
Anesthesia protocol all patients was administered 300 mg of oral ranitidine the night before
the surgery and 10 mg IV metoclopramide in combination with 150 mg ranitidine 1 h before
arrival to the operating room. Upon the arrival to the operating room, an electrocardiogram,
noninvasive blood pressure, SpO2, rSO2 (Masimo oximeter), and neuromuscular monitoring
(TOF-Watch SX; Organon, Dublin, Ireland) were performed on the patients. Afterward,
preoxygenation was performed with 4 L/min oxygen (80%) for 3 min by using facemasks, and
anesthesia was induced with an IV propofol injection (1.5-2.5 mg/kg of ideal body weight) and
an IV bolus administration of remifentanil (1 lg/kg of lean body weight [LBW]) for 30-60 s,
and then switched to infusion at 0.25 lg/kg of LBW/min. After the eyelid reflex disappeared,
a neuromuscular blockade was performed using rocuronium (1.2 mg/kg of LBW) and tracheal
intubation was done. Volume-controlled mechanical ventilation was applied. Breathing gases
(oxygen, carbon dioxide and sevoflurane), the tidal volume were set as 7-8 mL/kg of LBW,
inspiratory:expiratory ratio as 1:2, positive end-expiratory pressure as 5-8 cmH2O, and the
respiratory rate was determined to obtain an end-tidal carbon dioxide partial pressure
(PETCO2) of 32-37 mmHg. These ventilator settings were not changed throughout the operation.
Oxygen/air (fraction of inspired oxygen [FiO2] of 0.40), inspiratory fresh gas flow of 2
L/min), sevoflurane (1 minimum alveolar concentration [MAC]), and remifentanil IV infusion
(0.1-0.25 lg/kg of LBW/min) were used in the for the maintenance of anesthesia. Neuromuscular
blockade was performed during the operation by rocuronium infusion (0.3- 0.7 mg/kg of LBW/h).
IV normal saline or lactated Ringer's solution at 5-7 mL/kg of LBW was also used for
perioperative fluid maintenance. Nasopharyngeal temperature was monitored throughout the
surgery, and the patient temperature (36-37C) was ensured by using a forced-air warming
system for the maintenance of intraoperative normothermia during the procedure. After
anesthesia induction, a neutral head position of the patients was preserved to prevent
alteration of cerebral venous drainage. Carbon dioxide insufflation was performed with an
electronic laparoflator using a closed Veress needle technique, and intra-abdominal pressure
was automatically kept at the desired level (14-16 mmHg) during the surgery. After the
insufflation of carbon dioxide, the patients were positioned in a 30 reverse-Trendelenburg
and at a 10 right lateral position. At the end of the surgery, the blockade was reversed by
administering 4 mg/kg of adjusted body weight sugammadexwith a PTC of 1-2. All patients were
extubated when fully awake. The patients were referred to the recovery unit and monitored for
50 min for complications. In cases where no complications was apparent, the recovery was
evaluated using the modified Aldrete scoring system. Once the score was ≥9, the patients were
taken to the unit. For postoperative nausea and vomiting, 4-5 mg dexamethasone was used
(except for diabetic patients on insulin) 90 min before anesthesia induction and 4-8 mg IV
ondansetron 20-30 min before the end of the operation. For postoperative pain management, 1 g
IV acetaminophen was administered 20 min after induction and 30 mg IV ketorolac 20 min before
onset. Then, 1 g IV acetaminophen was administered every 6 h + 50 mg IV dexketoprofen every 8
h for the first 48 h. In addition, morphine was administered using a patient-controlled
analgesia delivery system (demand dose, 20 lg/kg of ideal body weight; lockout time, 6-10
min; 4 h limit, 80% of the total calculated dosage) for 48 h postoperatively.
Intraoperative measurements, physiological variables including heart rate (HR), MAP, SpO2,
and PETCO2 were recorded preoperatively, 1 min after the induction, and every 5 min until the
patient was referred to the recovery unit. The MAP and HR values were allowed to fluctuate up
to 20% of the preoperative values of the patients. For this purpose, the infusion rate of
remifentanil was accordingly increased and decreased. When hypotension (MAP ˂60 mmHg) or
bradycardia (HR˂45beats/min) continued for longer than 3 min, they were treated with 5 mg
ephedrine and 0.5 mg atropine, respectively. Patients who received ephedrine or atropine more
than twice were excluded from the study.
Cerebral oxygen saturation. The rSO2 values of the patients were recorded preoperatively, 1
min after the induction, and every 5 min until the patient was referred to the recovery unit.
Measurements in the last 30 s of preoxygenation, performed for 3 min with 4 L/min oxygen
(80%) preinduction was accepted as preoperative values. To assess rSO2, cerebral oximetry
sensors were placed at least 2 cm above the left and right eyebrows and 3 cm from the midline
(to prevent the sagittal sinus from influencing the results) before the induction in
accordance with the manufacturer's instructions. Before applying the sensor pads, the
forehead of the patient was cleaned with acetone alcohol and bandaged to protect the sensors
from ambient light and to keep them stable. Cerebral oxygen desaturation was defined as a
>25% decrease in the rSO2 value compared with the preoperative value (decrease should be more
than 20% if the preoperative value was˂50) and maintenance of this situation for≥15s. In this
case, the following algorithm was used. First of all, normotension of the patient was ensured
(administration of vasopressors such as ephedrine, and/or infusion of isotonic fluids) and
the patient's neck were checked. Operating times. anesthesia, surgery, pneumoperitoneum, and
recovery times were recorded. Recovery time was defined as the time from discontinuation of
sevoflurane or propofol and remifentanil at the end of the surgery to the restoration of
spontaneous breathing, opening of the eyes upon a verbal command, squeezing of the hand of
the observer and extubation. Additionally, the complications (including nausea and vomiting)
developed by the patients were also recorded.
