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Comparison of Ramelteon with Clonidine as an Adjuvant to Anesthesia: A Placebo‑controlled, Randomized, Double‑blinded Trial


Affiliations
1 Departments of Anaesthesia, Institute of Post Graduate Medical Education and Research Hospital, India
2 Department of Psychiatry, RG Kar Medical College, Kolkata, India
3 Psychiatry, Institute of Post Graduate Medical Education and Research Hospital
4 Department of Anaesthesia, Burdwan Medical College, Burdwan, West Bengal, India
5 Psychiatry, Institute of Post Graduate Medical Education and Research Hospital, India
 

Context: We have evaluated the effect of ramelteon, clonidine, and a placebo on perioperative sedation, anxiety, cognition, and postoperative analgesia in cases of laparoscopic cholecystectomies. Aims: To study the comparative efficacy of ramelteon and clonidine on sedation and in reducing anxiety perioperatively. Settings and Design: Prospective, randomized, double‑blinded, placebo‑controlled trial. Materials and Methods: Ninety patients undergoing laparoscopic cholecystectomies were randomized into the following three groups; the control group (placebo), the clonidine group, and the ramelteon group. The sedation, anxiety, orientation scores, psychomotor functions, the hemodynamic parameters, and the recall and total analgesic consumption postoperatively for 24 h were assessed. Statistical Analysis Used: Statistical analysis was done with Student’s t‑test for the quantitative data and Chi‑square test for the categorical data. Results: The anxiety scores were significantly lower in both the clonidine group and the ramelteon group in comparison to the placebo group. Higher level of sedation was noted in the clonidine and ramelteon groups compared to the placebo group. Patient satisfaction score was significantly higher in the clonidine group. Analgesic consumption was noted to be significantly less in the clonidine group. Statistically significant reduction in the mean arterial pressure (MAP) and heart rate were observed in the clonidine group. Conclusions: We observed that oral premedication of ramelteon and clonidine resulted in a significant level of sedation and reduction of anxiety score with no significant impairment of the psychomotor functions compared to the placebo. The clonidine group, in addition, showed significant analgesic sparing effect in the first 24 h and reduction in the MAP and heart rate pre‑ and postoperatively.

Keywords

Clonidine, melatonin, perioperative sedation, ramelteon
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  • Comparison of Ramelteon with Clonidine as an Adjuvant to Anesthesia: A Placebo‑controlled, Randomized, Double‑blinded Trial

Abstract Views: 135  |  PDF Views: 76

Authors

Suchismita Mallick
Departments of Anaesthesia, Institute of Post Graduate Medical Education and Research Hospital, India
Uday S. Mandal
Department of Psychiatry, RG Kar Medical College, Kolkata, India
Ajay Halder
Psychiatry, Institute of Post Graduate Medical Education and Research Hospital
Sumanta G. Moulik
Department of Anaesthesia, Burdwan Medical College, Burdwan, West Bengal, India
Sandip Kr Hazra
Psychiatry, Institute of Post Graduate Medical Education and Research Hospital, India
Abhinanda Biswas
Psychiatry, Institute of Post Graduate Medical Education and Research Hospital, India

Abstract


Context: We have evaluated the effect of ramelteon, clonidine, and a placebo on perioperative sedation, anxiety, cognition, and postoperative analgesia in cases of laparoscopic cholecystectomies. Aims: To study the comparative efficacy of ramelteon and clonidine on sedation and in reducing anxiety perioperatively. Settings and Design: Prospective, randomized, double‑blinded, placebo‑controlled trial. Materials and Methods: Ninety patients undergoing laparoscopic cholecystectomies were randomized into the following three groups; the control group (placebo), the clonidine group, and the ramelteon group. The sedation, anxiety, orientation scores, psychomotor functions, the hemodynamic parameters, and the recall and total analgesic consumption postoperatively for 24 h were assessed. Statistical Analysis Used: Statistical analysis was done with Student’s t‑test for the quantitative data and Chi‑square test for the categorical data. Results: The anxiety scores were significantly lower in both the clonidine group and the ramelteon group in comparison to the placebo group. Higher level of sedation was noted in the clonidine and ramelteon groups compared to the placebo group. Patient satisfaction score was significantly higher in the clonidine group. Analgesic consumption was noted to be significantly less in the clonidine group. Statistically significant reduction in the mean arterial pressure (MAP) and heart rate were observed in the clonidine group. Conclusions: We observed that oral premedication of ramelteon and clonidine resulted in a significant level of sedation and reduction of anxiety score with no significant impairment of the psychomotor functions compared to the placebo. The clonidine group, in addition, showed significant analgesic sparing effect in the first 24 h and reduction in the MAP and heart rate pre‑ and postoperatively.

Keywords


Clonidine, melatonin, perioperative sedation, ramelteon