Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.

Spine Surgery Clinical Trial

Official title:

Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301025
• Other study ID #: R/17.07.107
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elective lumbar spine surgical procedures are commonly performed under controlled hypotension during general anesthesia. That is beneficial to limit the intraoperative blood loss and transfusions and improves surgical field. Deliberate hypotension could be achieved via various medications but mostly associated with significant side effects. Pregabalin effectively augmented hypotensive anesthesia. The hypothesis is that Pregabalin 150 mg single preoperative dose may augment intraoperative deliberate hypotension that will be reflected on blood loss and nitroglycerin consumption.

Description:

An arterial line will be established then general anesthesia will be conducted. After adequate preoxygenation, anesthesia induction by IV fentanyl 1.5µg/kg, propofol 2 mg/kg, and atracurium 0.5 mg/kg then appropriated size tracheal tube. The ventilator settings will be adjusted to maintain the end-tidal carbon dioxide tension (ETco2) at 30-35 mm Hg. Anesthesia will be maintained by isoflurane concentration 1.2%, with 40% oxygen in air then IV infusion of fentanyl 0.05 mcg/kg/min was started while atracurium 0.1 mg/kg incremental dose as required. Then patients will be turned into the prone position above pad support permitting free hanging of the abdomen. Intraoperatively, the target mean arterial arterial blood pressure (MBP) is 55-65 mm Hg. After surgical incision, if MBP exceeds 65 mm Hg (defined as hypertension) it will be managed by: increasing isoflurane MAC up to 2%, if no response after 5 min, Nitroglycerin infusion initiated at 0.5 mcg/kg/min to 40 mcg/kg/min. Hypotension (MBP <55 mm Hg) will be treated by stopping nitroglycerin, proper compensation of losses, reducing Isoflurane MAC. If persisted; vasoactive drugs will be used. Bradycardia (HR <50 beat/min.), treated with 0.01 mg/kg atropine IV increments.

The nitroglycerin infusion will be stopped after the finial surgical hemostasis. Fentanyl infusion will be stopped before ligament sutures. Isoflurane will be closed after the last surgical suture. After dressing, patient will be turned to the supine position and morphine 0.025 mg/kg IV will be administered then 0.04 mg/kg neostigmine and 0.015 mg/kg atropine for reversal. Extubation will be done after establishment of acceptable spontaneous respiration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 30, 2019
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) score I-II

• admitted to undergo lumbar discectomy or spinal fixation surgery under general anesthesia

Exclusion Criteria:

• Patients on anti-hypertensive treatment, diuretics, corticosteroids, pregabalin, gabapentin, anticonvulsants, antipsychotics,

• alcohol addiction or drug abuse

• patients with history of allergy to any drug used in the study .

• pregnant or nursing women

• patients with peripheral neuropathy, endocrinal diseases, bleeding abnormality,

• cardiac, hepatic or renal impairment

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Drug:
• Pregabalin
Pregabalin 150 mg capsule, one h preinduction of general anesthesia
• placebo
given a placebo identical capsule once one hour before anesthesia

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansourah	Dakahlia
Egypt	Delta Hospital	Mansourah,	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nitroglycerin consumption	the total nitroglycerin consumption in milligram to maintain the target mean arterial pressure (MAP) 55- 65 mmHg.	Intraoperative
Secondary	Estimated blood loss	towels are weighted, plus suction volume without irrigation fluids in milliter.	intraoperative
Secondary	The number of transfused blood unites	Packed red blood cell unites	intraoperative
Secondary	heart rate (HR)	in beat/min	Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.
Secondary	end-tidal isoflurane concentration	in percent	at 30, 60, 90, 120, 150 , 180, 210 minutes after intubation.
Secondary	Surgeon satisfaction about the field	using a six-point scale (0 = no bleeding, virtually bloodless field; 5 = uncontrolled) bleeding).	within 2 hours from the end of surgery.
Secondary	Sedation	(Ramsay sedation scale)	at 0, 2, 4, 6, 12, 24 hours postoperatively
Secondary	The time to the first request of analgesia.	in hours	24 hours postoperative
Secondary	Postoperative pain	(VAS 0-10 scale) 10 is the worst pain	at 0, 2, 4, 6, 12, 24 hours postoperatively.
Secondary	The total morphine consumption	in mg	in the 1st 24 hours postoperatively
Secondary	Frequency of adverse effects	dizziness, headache, nausea and vomiting, or pruritus.	during the first 24 hours postoperatively
Secondary	Peak airway pressures	in centimeter water	10 minutes after settled prone position
Secondary	invasive mean arterial blood pressure (MAP)	in millimeter mercury (mmHg)	Basal, during intubation, then at 1, 5, 30, 60, 90, 120, 150, 180, 210 minutes post extubation, then postoperatively at 1 and 2 hours.