The sedation effect of midazolam-fentanyl and midazolam-propofol combination in patients with elective upper gastrointestinal endoscopy in Ali ebne Abitaleb Hospital, Zahedan, in 2018

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190714044207N1

Enrollment

140

Registered

2019-07-25

Start date

2017-03-21

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: The sedative effect of the medication on endoscopic digestive system. Condition 2: The sedative effect of the medication on endoscopic digestive system. Abdominal and pelvic pain Other symptoms and signs involving the digestive system and abdomen

Interventions

Intervention 1: Intervention group: IV infusion of midazolam + fentanyl (F), midazolam, mcg / kg 15, fentanyl 0.15 mg / kg. Intervention 2: Intervention group:IV infusion of midazolam + propofol (P )

Eligibility

Sex/Gender

All

Age

20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patient candidated for upper GI endoscopy 20-70 years old ASA class =3

Exclusion criteria

Exclusion criteria: Heart disease AS? IHD ? HTN?(HF EF<30%) Liver disease (Child-Pugh classification C) Renal disease (GFR<60%) Lack of patient cooperation Psychiatric Disease (Major Depression, Mania, Psychosis) SBP<90 Addiction Emergent endoscopy Allergy to egg and soybean

Design outcomes

Primary

Measure	Time frame
Blood Pressure in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device.;Arterial oxygen saturation in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device.;Sedation of drugs in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Ramsay sedation score (0-5).;The number of respiration in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device.;The number of heart rate in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device.	—

Measure

Time frame

Blood Pressure in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device.;Arterial oxygen saturation in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device.;Sedation of drugs in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Ramsay sedation score (0-5).;The number of respiration in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device.;The number of heart rate in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device.

—

Secondary

Measure	Time frame
Comparison of vital signs after endoscopy. Timepoint: When the patient is transferred to the recovery room. Method of measurement: Monitoring device of vital signs.;The satisfaction of sefation of two drug regimens. Timepoint: After Endoscopy End. Method of measurement: Anesthesiology Resident Skill and Experience.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDoctor Sakineh Sheikh

Zahedan University of Medical Sciences

sakine.sheikh@gmail.com+98 54 3329 5715

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026