Evaluation of the effect of fentanyl or sulfentanil on spinal anesthesia in cesarean section

Comparison the effect of composition of fentanyl or interathecal suffentanil with 0.5 hyperbaric bupivacaine in spinal anesthesia in elective cesarean patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20171109037340N1

Enrollment

Registered

2018-03-10

Start date

2017-02-08

Completion date

Unknown

Last updated

2018-03-26

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

Conditions

Cesarean section. Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section

Interventions

Intervention 1: First intervention group: receiving 20 µg fentanyl plus 0.5% hyperbaric bupivacaine. Intervention 2: Second intervention group: receveing 5.2 µg sufentanil plus 0.5% hyperbaric bupivac

Eligibility

Sex/Gender

Female

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Term pregnancy Primigravida ASA class 1 and 2 Cesarean section due to cephalopelvic disproportion

Exclusion criteria

Exclusion criteria: spinal anesthesia contraindication Gestational hypertension Gestational diabetes Placenta previa

Design outcomes

Primary

Measure	Time frame
Analgesia quality. Timepoint: Immediately after drug injection. Method of measurement: Based on 4 grades; Excellent: During the procedure, patients feel comfortable with no complainment. Good: brief discomfort with no need of additional medication. Moderate: Unpleasant but controllable with additional medication such as phenthanyl, propofol, dormicom and the like. Poor: Inability to control even with an additional drug.;The duration of effective analgesia. Timepoint: The interval between the initiation of drug administration in each group until the first request of analgesia by patients. Method of measurement: 1-awake and anxious; 2- awake and calm; 3- sleepy but easily awake; 4- sleepy but not easily awake.;Duration of discharge. Timepoint: The interval between the initiation of drug administration in each group until the time of discharge from hospital. Method of measurement: Day.	—

Measure

Time frame

Analgesia quality. Timepoint: Immediately after drug injection. Method of measurement: Based on 4 grades; Excellent: During the procedure, patients feel comfortable with no complainment. Good: brief discomfort with no need of additional medication. Moderate: Unpleasant but controllable with additional medication such as phenthanyl, propofol, dormicom and the like. Poor: Inability to control even with an additional drug.;The duration of effective analgesia. Timepoint: The interval between the initiation of drug administration in each group until the first request of analgesia by patients. Method of measurement: 1-awake and anxious; 2- awake and calm; 3- sleepy but easily awake; 4- sleepy but not easily awake.;Duration of discharge. Timepoint: The interval between the initiation of drug administration in each group until the time of discharge from hospital. Method of measurement: Day.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Arefpour

Zahedan University of Medical Sciences

Dr.arefpour@zaums.ac.ir+98 54 3329 5744

Outcome results

None listed

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