Combination of Neostigmine and Metoclopramide to reduce gastric residual volume in mechanically ventilated ICU patients

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT201408104365N16
• Date of registration: 2015-01-01
• Prospective Registration: No
• Primary sponsor: Vice chancellor for research of Mazandaran University of Medical Sciences
• Public title: Combination of Neostigmine and Metoclopramide to reduce gastric residual volume in mechanically ventilated ICU patients
• Scientific title: The effect of combination of Neostigmine and Metoclopramide on gastric residual volume in mechanically ventilated ICU patients
• Date of first enrolment: 2014-03-01
• Target sample size: 90
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/4663
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
• Phase: 2-3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Afshin Gholipour Baradari, MD
• Affiliation: Mazandaran University of Medical Sciences

• Name: Afshin Gholipour Baradari, MD
• Affiliation: Mazandaran University Of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: patient family agreement and informed written consent; under mechanical ventilation; nutrition via gastric tube; gastric residual volume greater than 120 cc; age between 20 and 60 years
Exclusion criteria: diabetes; heart rate<60; heart blocks and arrhythmias; systolic BP<90 mmHg; hypothermia (core temperature<35); renal failure (serum Creatinin>1.5 in two consecutive test); prokinetic agents consumption during 8 hours before intervention; recent surgery on GI tract within 10 days; pregnancy and breast feeding; extrapyramidal sign; bronchospasm; hypokalemia (K<3 meq/L); known sensitivity to Neostigmine and metoclopramide; GI bleeding.
Exclusion criteria:

Age minimum: 20 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

The relation of combination of Neostigmine and Metoclopramide with gastric residual volume in mechanically ventilated ICU patients.

Intervention(s)

Intrvention group 3: Neostigmine 2.5 mg + Metoclopramide 10 mg in 100 ml normal saline infused during 30 minute at the beginning of trial

Intervention 1: Intrvention group 1: Neostigmine 2.5 mg in 100 ml normal saline infused during 30 minute at the beginning of trial. Intervention 2: Intrvention group 2: Metoclopramide 10 mg in 100 ml normal saline infused during 30 minute at the beginning of trial. Intervention 3: Intrvention group 3: Neostigmine 2.5 mg + Metoclopramide 10 mg in 100 ml normal saline infused during 30 minute at the beginning of trial.

Intrvention group 1: Neostigmine 2.5 mg in 100 ml normal saline infused during 30 minute at the beginning of trial

Intrvention group 2: Metoclopramide 10 mg in 100 ml normal saline infused during 30 minute at the beginning of trial

Treatment - Drugs

Primary Outcome(s)

Gastric residual volume. Timepoint: 0,3,6,9,12 hours after intervention. Method of measurement: Gastric lavage.

Secondary Outcome(s)

Albumin, hemoglobin, WBC, Na, K, Mg. Timepoint: Before trial. Method of measurement: laboratory kit.

Hear rate, blood pressure. Timepoint: During trial. Method of measurement: Cardiac monitoring.

SOFA. Timepoint: before trial. Method of measurement: SOFA calculator.

Source(s) of Monetary Support

Vice chancellor for research of Mazandaran University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Mazandaran University of Medical Sciences