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Effect of Dexmedetomidine and Remifentanil on Postoperative Pain in Obese Patients

Comparison of Dexmedetomidine and Remifentanil in Postoperative Pain Control in Obese Patients Undergoing Sleeve Gastrectomy: A Randomized Double-Blind Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250331065185N1
Enrollment
100
Registered
2026-02-07
Start date
2026-02-19
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Condition 1: postoperative pain. Condition 2: obesity. Other acute postprocedural pain Morbid (severe) obesity due to excess calories

Interventions

Intervention 1: Intervention group 1: DexmedetomidineIn this group, patients undergo general anesthesia for sleeve gastrectomy. Dexmedetomidine is administered as follows:A loading dose of dexmedetomi

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Obese patients scheduled for elective sleeve gastrectomy Ability to understand and cooperate with postoperative pain assessment Provision of written informed consent to participate in the study Undergoing surgery under general anesthesia American Society of Anesthesiologists (ASA) physical status class I or II Body mass index (BMI) = 35 kg/m² Age between 18 and 70 years

Exclusion criteria

Exclusion criteria: History of hypersensitivity or allergic reaction to dexmedetomidine, remifentanil, or other opioids Inability or unwillingness to provide written informed consent Requirement for concurrent surgical procedures other than sleeve gastrectomy Pregnancy or breastfeeding Psychiatric or neurological disorders interfering with cooperation or pain assessment Chronic use of opioids, sedatives, or substance abuse Severe respiratory disease or untreated obstructive sleep apnea Severe hepatic or renal impairment Presence of severe or unstable cardiovascular disease (e.g., significant arrhythmias or advanced heart failure)

Design outcomes

Primary

MeasureTime frame
Postoperative pain intensity after sleeve gastrectomy. Timepoint: Pain intensity will be assessed at 1, 6, 12, and 24 hours after completion of surgery. Method of measurement: Pain intensity will be measured using the Visual Analogue Scale, consisting of a ten-centimeter horizontal line anchored by no pain at one end and worst imaginable pain at the other end.;Total rescue analgesic consumption within the first twenty-four hours after sleeve gastrectomy. Timepoint: Rescue analgesic consumption will be recorded during the first twenty-four hours after completion of surgery. Method of measurement: The total amount of rescue analgesics administered will be calculated as morphine equivalent dose in milligrams based on nursing and medical records.;Time to first analgesic request after sleeve gastrectomy. Timepoint: The time interval from completion of surgery to the patient’s first request for analgesic medication will be recorded. Method of measurement: The time interval in minutes will be measured based on the recorded time of surgery completion and the time of the first analgesic request documented in the nursing records.

Secondary

MeasureTime frame
Incidence of postoperative nausea and vomiting during the first twenty four hours after sleeve gastrectomy. Timepoint: Postoperative nausea and vomiting will be assessed at predefined intervals during the first twenty four hours after completion of surgery. Method of measurement: The presence or absence of nausea and vomiting will be recorded based on patient reports and nursing observations documented in the medical records.;Changes in blood pressure and heart rate during the first twenty four hours after sleeve gastrectomy. Timepoint: Blood pressure and heart rate will be measured and recorded at predefined intervals during the first twenty four hours after completion of surgery. Method of measurement: Blood pressure and heart rate will be measured using standard patient monitoring and recorded in the nursing and medical records.;Time to emergence from anesthesia after completion of sleeve gastrectomy. Timepoint: From discontinuation of anesthetic agents until full emergence of the patient after completion of surgery. Method of measurement: The time interval from discontinuation of anesthetic agents until full emergence of the patient will be recorded based on clinical observation and medical records, measured in minutes.;Duration of stay in the post anesthesia care unit after sleeve gastrectomy. Timepoint: From admission to the post anesthesia care unit until discharge from the unit after completion of surgery. Method of measurement: Time of admission to and discharge from the post anesthesia care unit will be recorded from nursing and medical records, and the duration of stay will be calculated in minutes.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaede Karimian

Shahid Beheshti University of Medical Sciences

m_karimian1990@yahoo.com009823515

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026