ClinicalTrials.gg
CompletedNCT03386565Updated Dec 29, 2017

Effect of Intraoperative Lidocaine Infusion on Intraoperative Isoflurane Requirements

An interventional study of sodium chloride solution and Lidocaine in Anesthesia, sponsored by Assiut University. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-12-29.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Oct 2016, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Fifty patients were included in the study, divided into two equal groups (25 in each), underwent spinal fusion surgery.Control group: received normal saline.

Lidocaine group: received lidocaine 2.0 mg/kg slowly IV before induction of anesthesia, followed by lidocaine IV infusion at a rate of 2.5 mg/kg/hr until the end of surgery. We evaluated the end-tidal isoflurane concentration required to maintain AAI index in the range of 20-25 during adult spinal fusion surgery.

Read the detailed description

This prospective, double-blinded, randomized study was carried out in Assiut University Hospitals, after approval by the local research ethics committee of Assiut Faculty of Medicine, Egypt. Informed consent was taken from each patient.

Patients were randomly allocated into two groups of equal size to receive either 0.9% sodium chloride infusion group 1 (CG), or lidocaine infusion group 2 (LG). Randomization was performed using G1 and G2 registers, which was placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who prepared the intravenous solution and identified it with the patient number, according to the envelope drawn. The solution was handed to another physician, blind to the prepared solutions' content, who was responsible for the anesthesia. The solution volume was equal. The responsible investigator was remained blind to the chosen group until the end of the study. G1 patients (n = 25) were received 10 mL of 0.9% sodium chloride slowly IV just before induction of anesthesia, then infused through 50 mL syringe as lidocaine, and G2 patients (n = 25) were received a loading dose of lidocaine 2 mg ̸ kg (maximally 200 mg) slowly IV just before induction of anesthesia, then the lidocaine infusion started immediately after positioning at a rate of 2.5 mg ̸ kg/h until the end of the procedure (50 mL syringe contained 25 mL 2.0% lidocaine i.e., 500 mg lidocaine plus 25 mL normal saline). Both syringes (10 mL for loading dose and 50 mL for maintenance IV infusion) were labelled by the case number and prepared by another anesthesiologist who did not share in anesthesia.

Anesthesia technique: Patients were monitored with continuous electrocardiography, pulse oximetry and intermittent non-invasive blood pressure measurements every 5 min. Capnography, end-tidal isoflurane concentration (Et-Iso) via AVANCE CS2 Datex-Ohmeda, Inc. USA, and auditory evoked potential monitor (AEP monitor 2 Dia Trade medical engineering) also attached to the patient (one AEP electrode was placed on the center of the forehead, one on the temple, and one behind the left ear over the mastoid bone).

General anesthesia was induced by propofol 2.5 mg ̸ kg and cisatracurium 0.15 mg ̸ kg to facilitate endotracheal intubation. Patients were then assigned to two groups by closed-envelope randomization. In both groups, anesthesia was maintained with isoflurane in oxygen/air mixture at sufficient concentration to maintain AAI index in the range 20-25, and mean blood pressure within 25% of the baseline value. All patients were received 60 mg ketorolac (ketolac) slowly IV after induction of anesthesia, and fentanyl 1.5 µg ̸ kg IV before skin incision and 0.5 µg ̸ kg given IV after 45 min. Reversal of residual muscle relaxant was done using neostigmine and atropine at the end of the operation.

Data collection: Demographic and surgical data include: Age, gender, weight, height, duration and type of surgery, in addition to Et-Iso.

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients underwent spinal fusion surgery , II and III

Exclusion criteria

Exclusion Criteria:

  • History of epilepsy hearing disorders known allergy to lidocaine > 35 significant cardiac diseases significant renal diseases liver dysfunction substance abuse chronic opioid use
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    control group

    * Sodium chloride solution 10 mL IV just before induction of anesthesia * IV infusion during the surgery

    Drug: sodium chloride solution

  • Active comparator
    lidocaine group

    * lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia * IV infusion during the surgery

    Drug: Lidocaine

Interventions

  • Drugsodium chloride solution

    intraoperative IV infusion

    Also known as: normal saline solution

  • intraoperative IV infusion

    Also known as: xylocaine

06

What researchers measure

Primary outcomes

  1. effect of intraoperative IV lidocaine infusion on intraoperative end tidal isoflurane concentration

    using gas analyzer for determination of end tidal isoflurane concentration (%) (ET-Iso) needed to maintain AAI index in the range 20-25.

    Time frame: every 15 minutes from induction of anesthesia until 90 minutes intraoperative.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Vesal N, Spadavecchia C, Steiner A, Kirscher F, Levionnois OL. Evaluation of the isoflurane-sparing effects of lidocaine infusion during umbilical surgery in calves. Vet Anaesth Analg. 2011 Sep;38(5):451-60. doi: 10.1111/j.1467-2995.2011.00636.x. PubMed 21831050 ↗
  • Saadawy IM, Kaki AM, Abd El Latif AA, Abd-Elmaksoud AM, Tolba OM. Lidocaine vs. magnesium: effect on analgesia after a laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 2010 May;54(5):549-56. doi: 10.1111/j.1399-6576.2009.02165.x. Epub 2009 Nov 16. PubMed 19919581 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2016 to primary completion in Oct 2017, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2017
First posted
Dec 29, 2017
StartActual
Oct 2, 2016
Primary completionActual
Oct 2, 2017
CompletionActual
Dec 15, 2017
Last update
Dec 29, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03386565
Lead sponsor
Assiut University
Responsible party
Mohamed galal aly (Assistant Professor, Assiut University) — Principal investigator
First posted
Dec 29, 2017
Start date
Oct 2, 2016
Primary completion
Oct 2, 2017
Completion
Dec 15, 2017
Last update
Dec 29, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Lidocaine

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