Esketamine Administration on Recovery Quality After Radical Mastectomy

Sponsor

Anqing Municipal Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05289440

Collaborator

(none)

130

Enrollment

Location

Arms

8.6

Anticipated Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Some studies have reported that intravenous esketamine reduce postoperative pain intensity. The investigators investigated whether esketamine could improve the the quality of recovery after modified radical mastectomy.

Condition or Disease	Intervention/Treatment	Phase
Esketamine and the Quality of Recovery	Drug: Low-dose esketamine infusion Drug: High-dose esketamine infusion Drug: Saline infusion	N/A

Detailed Description

A total of 111 patients were randomly allocated into 3 groups. Patients in group LE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin. Patients in group HE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin. Patients in group CON received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Esketamine on the Quality of Recovery After Modified Radical Mastectomy

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Nov 15, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-dose esketamine infusion on the quality of recovery after radical mastectomy Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.	Drug: Low-dose esketamine infusion Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin. Drug: High-dose esketamine infusion Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin. Drug: Saline infusion Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.
Experimental: High-dose esketamine infusion on the quality of recovery after radical mastectomy Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.	Drug: Low-dose esketamine infusion Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin. Drug: High-dose esketamine infusion Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin. Drug: Saline infusion Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.
Experimental: Saline infusion on the quality of recovery after radical mastectomy Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.	Drug: Low-dose esketamine infusion Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin. Drug: High-dose esketamine infusion Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin. Drug: Saline infusion Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

Arm

Intervention/Treatment

Experimental: Low-dose esketamine infusion on the quality of recovery after radical mastectomy

Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.

Drug: Low-dose esketamine infusion

Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.

Drug: High-dose esketamine infusion

Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.

Drug: Saline infusion

Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

Experimental: High-dose esketamine infusion on the quality of recovery after radical mastectomy

Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.

Drug: Low-dose esketamine infusion

Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.

Drug: High-dose esketamine infusion

Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.

Drug: Saline infusion

Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

Experimental: Saline infusion on the quality of recovery after radical mastectomy

Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

Drug: Low-dose esketamine infusion

Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin.

Drug: High-dose esketamine infusion

Patients received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin.

Drug: Saline infusion

Patients received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

Outcome Measures

Primary Outcome Measures

Quality of recovery scores (QoR-15) [1 day after operation]
Our primary outcome was quality of recovery scores (QoR-15) 1 day after operation

Secondary Outcome Measures

Pain visual analogue scale scores [The first 48 hours after operation]
Secondary Outcome Measure was pain visual analogue scale scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status
Scheduled for elective modified radical mastectomy

Exclusion Criteria:

Severe respiratory disease
Renal or hepatic insufficiency
History of preoperative psychiatric
Preoperative hypertension
Preoperative history of chronic pain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anqing Hospital Anesthesiology	Anqing	Anhui	China	246000

Sponsors and Collaborators

Anqing Municipal Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anqing Municipal Hospital

ClinicalTrials.gov Identifier:

NCT05289440

Other Study ID Numbers:

Zhumin

First Posted:

Mar 21, 2022

Last Update Posted:

May 4, 2022

Last Verified:

May 1, 2022

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

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

Keywords provided by Anqing Municipal Hospital

Esketamine

The quality of recovery

Additional relevant MeSH terms:

Esketamine

Study Results

No Results Posted as of May 4, 2022