The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT06037135

Collaborator

(none)

Enrollment

Location

Arms

99.7

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators planned this study to investigate the effects of dexmedetomidine administration on intraoperative hemodynamic stability in patients with pheochromocytoma.

Condition or Disease	Intervention/Treatment	Phase
Pheochromocytoma	Drug: dexmedetomidine Drug: 0.9% normal saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study

Actual Study Start Date :

Dec 3, 2012

Actual Primary Completion Date :

Mar 26, 2021

Actual Study Completion Date :

Mar 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dexmedetomidine group In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery.	Drug: dexmedetomidine In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group.
Active Comparator: Control group In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.	Drug: 0.9% normal saline In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.

Arm

Intervention/Treatment

Experimental: dexmedetomidine group

In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery.

Drug: dexmedetomidine

In the dexmedetomidine group, dexmedetomidine is administered at a rate of 0.5 μg/kg/h immediately after anesthesia induction and continued until the completion of the surgery. The research nurse, who did not participate in the study other than the management and preparation of the study medication, prepared 50mL of 0.9% normal saline for the control group and a mixture of dexmedetomidine 2 mL and 0.9% normal saline 48 mL (at a concentration of 4 μg/mL) for the dexmedetomidine group.

Active Comparator: Control group

In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.

Drug: 0.9% normal saline

In the control group, a 0.9% normal saline infusion is initiated at the same rate immediately after anesthesia induction and continued until the end of the operation.

Outcome Measures

Primary Outcome Measures

Intraoperative hemodynamic stability ( maximum blood pressure during surgery (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP)) [during operation]
Intraoperative hemodynamic stability (duration of SBP increase by 30% or more from baseline (in minutes) [during operation]
Intraoperative hemodynamic stability (duration of SBP exceeding 200 mmHg) [during operation]
Intraoperative hemodynamic stability (maximum HR during surgery) [during operation]
Intraoperative hemodynamic stability (duration of HR exceeding 110 beats per minute during surgery) [during operation]
Intraoperative hemodynamic stability (comparison of the quantity of vasoactive drugs (nitroprusside, esmolol, norepinephrine) used during surgery) [during operation]

Secondary Outcome Measures

levels of catecholamines [immediately after anesthesia induction]
the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points
levels of catecholamines [immediately after removal of the pheochromocytoma]
the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points
levels of catecholamines [immediately after the completion of surgery]
the actual secretion levels of catecholamines, specifically epinephrine and norepinephrine, were measured at different time points

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ages of 20 and 70
American Society of Anesthesiologists(ASA) physical status classification I to III,
planned laparoscopic adrenalectomy for pheochromocytoma.

Exclusion Criteria:

emergency operation,
re-operation,
combined surgery with other departments,
body mass index (BMI) >32 kg/m2,
history of arrhythmias (especially AV nodal block) and ventricular conduction abnormalities,
uncontrolled hypertension (diastolic blood pressure >110mmHg)
bradycardia (heart rate < 40 beats per minute),
history of heart failure, hepatic and/or renal failure,
history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia),
history of beta-blocker therapy, 10) history of uncontrolled psychiatric disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Young Jun Oh, M.D., Ph.D., Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT06037135

Other Study ID Numbers:

4-2012-0577

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pheochromocytoma

Pain, Postoperative

Dexmedetomidine

Study Results

No Results Posted as of Sep 14, 2023