Effect of Aminophylline Bolus Versus Infusion on Recovery Time in Patients Undergoing Lumbar Spine Surgery

NCT05655806 | Unknown Phase 4

• 1 other identifier: N-56-2022/MD
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To determine optimal dose, method and time of administration of aminophylline to enhance the recovery from general anesthesia. andTo estimate the recovery time from isoflurane closure in each group. We hypothesize that starting administration of loading and maintenance dose of aminophylline half an hour before discontinuing isoflurane will shorten the duration needed to extubate patients undergoing lumbar disc surgery. We hypothesized that it will yield superior results compared to bolus administration after discontinuing isoflurane.

Conditions

Anesthesia

Keywords

aminophylline; recovery time; time of extubation

Outcome Measures

Primary Outcomes (1)

• Recovery time

  Time to extubation from closure of isoflurane to extubation in minutes

  one hour

Secondary Outcomes (6)

• Response entropy (RE)

  4 hours

• State entropy (SE)

  4 hours

• Mean arterial blood pressure

  4 hours

• heart rate

  4 hours

• The total dose of aminophylline

  two hours

Study Arms (3)

group A

ACTIVE COMPARATOR

will receive aminophylline loading dose 5mg/kg on a 50 cm syringe using syringe pump over 5 minutes and maintenance dose 1.5 mg/kg/hr as a continuous infusion half an hour before discontinuation of isoflurane, and after discontinuation of isoflurane a 5 cm syringe of saline will be given over 5 minutes

Drug: Aminophylline bolus then infusion

group B

ACTIVE COMPARATOR

will receive a 50 cm syringe of saline using syringe pump over 5 minutes and maintenance continuous infusion of saline half an hour before discontinuation of isoflurane, and after discontinuation of isoflurane a 5cm syringe of aminophylline bolus 5mg\\kg will be given over 5 minutes

Drug: aminophylline bolus

group C

PLACEBO COMPARATOR

will receive a 50 cm syringe of saline using syringe pump over 5 minutes and maintenance continuous infusion of saline half an hour before discontinuation of isoflurane, and after discontinuation of isoflurane a 5 cm syringe of saline will be given

Drug: normal saline

Interventions

Aminophylline bolus then infusion DRUG

half an hour before discontinuation of isoflurane

group A

aminophylline bolus DRUG

after discontinuation of isoflurane

group B

normal saline DRUG

given as placebo

group C

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-II. 20-50 years old patients. Both sexes Patients undergoing single or double level lumbar laminectomy ,discectomy and/or fixation

You may not qualify if:

• Contraindications to the use of aminophylline as cardiac patients, patients with renal impairment, hepatic dysfunction, hypo or hyperthyroidism and epilepsy.
• Patients who have hypersensitivity to aminophylline Emergency operations. Operative time exceeding 5 hours

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy

Cairo, 11562, Egypt

RECRUITING

Related Publications (5)

• El Tahan MR. Effects of aminophylline on cognitive recovery after sevoflurane anesthesia. J Anesth. 2011 Oct;25(5):648-56. doi: 10.1007/s00540-011-1190-8. Epub 2011 Jul 14.

  PMID: 21755342 BACKGROUND

• Elsarrag M, Soldozy S, Patel P, Norat P, Sokolowski JD, Park MS, Tvrdik P, Kalani MYS. Enhanced recovery after spine surgery: a systematic review. Neurosurg Focus. 2019 Apr 1;46(4):E3. doi: 10.3171/2019.1.FOCUS18700.

  PMID: 30933920 BACKGROUND

• Wang Q, Fong R, Mason P, Fox AP, Xie Z. Caffeine accelerates recovery from general anesthesia. J Neurophysiol. 2014 Mar;111(6):1331-40. doi: 10.1152/jn.00792.2013. Epub 2013 Dec 26.

  PMID: 24375022 BACKGROUND

• Ghaffaripour S, Khosravi MB, Rahimi A, Sahmedini MA, Chohedri A, Mahmoudi H, Kazemi MR. The effects of Aminophylline on clinical recovery and bispectral index in patients anesthetized with total intravenous anaesthesia. Pak J Med Sci. 2014 Nov-Dec;30(6):1351-5. doi: 10.12669/pjms.306.5853.

  PMID: 25674137 BACKGROUND

• Wang HL, Tang SH, Wang XQ, Gong WH, Liu XM, Lei WF. Doxapram hastens the recovery following total intravenous anesthesia with dexmedetomidine, propofol and remifentanil. Exp Ther Med. 2015 Apr;9(4):1518-1522. doi: 10.3892/etm.2015.2249. Epub 2015 Feb 2.

  PMID: 25780462 BACKGROUND

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ahmed H. Sayed, M.D

CONTACT

+201068112464; drahmedhusseinanesth87@gmail.com

Rania s. Fahmy, M.D

CONTACT

+201270820372; ransam98@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: drugs will be prepared by another person who is not giving drugs or collecting data
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia , surgical ICU and pain managment

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 19, 2022
• Study Start: December 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)